OR_IMP_2

Description: |
The OR_IMP_2 table contains implant information specific to Mechanical Circulatory System and Implantable Cardioverter Defibrillator devices.

Primary Key

Column Name | Ordinal Position |
--- | --- | ---
IMPLANT_ID | 1 |

Column Information

| Name | Type | Discontinued? |
--- | --- | --- | --- | ---
1 | IMPLANT_ID | VARCHAR | No |
The unique identifier for the implant record.
2 | PRIMARY_DEVICE_YN | VARCHAR | No |
Specifies whether this is the patient's primary device.
May contain organization-specific values: No
Category Entries:
No
Yes
3 | DEVICE_EXPLANT_REASON_C_NAME | VARCHAR | No |
The category ID for the reason a device was explanted.
May contain organization-specific values: Yes
Category Entries:
Transplant
Device Malfunction - Elective
Device Malfunction - Emergent
Device Thrombosis - Elective
Device Thrombosis - Emergent
Infection - Emergent
Infection - Elective
Ventricular Recovery - Device Removed
Ventricular Recovery - Device Not Removed, Turned Off
4 | CONSOLE_TRACKING_NUM | VARCHAR | No |
The mechanical circulatory system device console tracking number.
5 | CANNULAE_LOC_INFLOW_C_NAME | VARCHAR | No |
The category ID for a device's cannulae inflow location.
May contain organization-specific values: Yes
Category Entries:
LA Appendage
LA Interatrial Groove
LA Apex
RA
RV
Unknown
6 | CANNULAE_LOC_OUTFLOW_C_NAME | VARCHAR | No |
The category ID for a device's cannulae outflow location.
May contain organization-specific values: Yes
Category Entries:
Abdominal Aorta
Ascending Aorta
Descending Aorta
Pulmonary Artery
Unknown
7 | DEVICE_STUDY_NUM | VARCHAR | No |
The device research study number.
8 | DEVICE_STRAT_TIME_IMP_C_NAME | VARCHAR | No |
The category ID for the intended treatment of an implanted mechanical circulatory device.
May contain organization-specific values: Yes
Category Entries:
Bridge to Recovery
Rescue Therapy
Bridge to Transplant (Currently Listed)
Possible Bridge to Transplant - Likely Eligible
Possible Bridge to Transplant - Moderate Likelihood
Possible Bridge to Transplant - Unlikely Eligible
Destination Therapy - Modifiable
Destination Therapy - Unmodifiable
Unknown
Other
9 | DEVICE_STRAT_TIME_IMP_FREETEXT | VARCHAR | No |
The intended treatment for an implanted mechanical circulatory device. This is a free-text field for describing values not found in Device Strategy At Time of Implant (I IMP 16507).
10 | ICD_CS_LV_SUCCESS_C_NAME | VARCHAR | No |
Indicates if the coronary sinus/left ventricular (CS/LV) lead was successfully implanted. This item corresponds to ICD Sequence 6145.
May contain organization-specific values: No
Category Entries:
Yes
Not Implanted
Previously Implanted
11 | ICD_CSLV_NT_IMP_C_NAME | VARCHAR | No |
Indicates the reason a Coronary Sinus Access or Left Ventricular (CS/LV) lead was not implanted.
May contain organization-specific values: No
Category Entries:
Vascular access
Coronary sinus access
Tributary vein access
Coronary sinus dissection
Unacceptable threshold
Diaphragmatic stimulation
12 | ICD_LET_SUCCESSFUL | INTEGER | No |
Indicates the lowest energy tested (LET) or defibrillation threshold that demonstrated that the device performs successfully (in joules).
13 | ICD_LET_NOT_TSTD_YN | VARCHAR | No |
Indicates the lowest energy tested (LET) that was successful was not tested.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
14 | ICD_ULV | INTEGER | No |
Indicates the upper limit of vulnerability (ULV) in joules.
15 | ICD_ULV_NOT_TEST_YN | VARCHAR | No |
Indicates the upper limit of vulnerability (ULV) was not tested.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
16 | ICD_REIMP_ENDBAT_YN | VARCHAR | No |
Indicates if a reason for reimplant is the end of expected battery life of a previous ICD.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
17 | ICD_REIMP_LEADRVN_YN | VARCHAR | No |
Indicates if a reason for reimplant is that the generator is being replaced at the time of lead revision.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
18 | ICD_REIMP_UPGRADE_YN | VARCHAR | No |
Indicates if a reason for reimplant is an upgrade of a previous device with additional pacing capabilities such as an upgrade from a single to a dual chamber device, or the replacement of a non-CRT with a CRT device.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
19 | ICD_REIMP_INFECTN_YN | VARCHAR | No |
Indicates if a reason for reimplant is due to infection in the location of the previously implanted device.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
20 | ICD_REIMP_MNRCALL_YN | VARCHAR | No |
Indicates if a reason for reimplant is that the previous device has been recognized by the manufacturer as demonstrating a recurring performance failure resulting in an advisory letter to physicians. This may or may not reach the level of a food and drug administration (FDA) designated recall. This also may or may not have led to device malfunction.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
21 | ICD_REIMP_FLTYHDR_YN | VARCHAR | No |
Indicates if a reason for reimplant is that there was a faulty connector/header which required Coding Instructions: another implant.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
22 | ICD_REIMP_DVRELOC_YN | VARCHAR | No |
Indicates if a reason for reimplant is that the device needed to be relocated because of a medical condition, or procedure near the original pocket. An example is if the patient was diagnosed with breast cancer and required treatment or surgery near the original implant.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
23 | ICD_REIMP_MALFUNC_YN | VARCHAR | No |
Indicates if a reason for reimplant is that the previous generator has malfunctioned. The device performance is outside the manufacturer's designated specification and cannot be resolved with reprogramming, necessitating in the replacement of the device, in the opinion of the physician.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
24 | ICD_MLFN_RSN_C_NAME | VARCHAR | No |
Indicates the reason for malfunction of the ICD implant.
May contain organization-specific values: No
Category Entries:
Atrial pacing
Left ventricular (LV) pacing
Right ventricular (RV) pacing
Defibrillation
Premature battery depletion
25 | ICD_ATPSHCK_DLVRD_YN | VARCHAR | No |
Indicates if, at any point in time, the ICD being removed had delivered antitachycardia pacing (ATP) or shock therapy.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
26 | ICD_ATPSHCK_APPRO_YN | VARCHAR | No |
Indicates if, at any point in time, the Implantable Cardioverter Defibrillator (ICD) being removed had delivered appropriate antitachycardia pacing (ATP) or shock therapy for spontaneous ventricular tachycardia and/or ventricular fibrillation.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
27 | ICD_ATP_SUCCESSFL_YN | VARCHAR | No |
Indicates if the antitachycardia pacing (ATP) therapy for ventricular tachycardia and/or ventricular fibrillation was successful.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
28 | ICD_SHCK_SUCCESS_YN | VARCHAR | No |
Indicates if the shock therapy for ventricular tachycardia and/or ventricular fibrillation was successful.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
29 | ICD_LD_PLCMNT_ISS_YN | VARCHAR | No |
Indicates if the existing lead had any placement issues.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
30 | ICD_LD_PERF_YN | VARCHAR | No |
Indicates if there was penetration of the existing lead through a systemic vein, coronary vein, or the myocardium.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
31 | ICD_PT_CLIN_STATS_YN | VARCHAR | No |
Indicates if a non-lead related medical or surgical procedure required the existing lead to be replaced.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
32 | ICD_LD_DISLDGEMNT_YN | VARCHAR | No |
Indicates if there was movement (macroscopic or microscopic) of an existing lead within the heart or vascular tree away from the original implantation site.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
33 | ICD_LEAD_INFCTION_YN | VARCHAR | No |
Indicates if there was a suspected or documented infection of the existing lead.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
34 | ICD_EROSION_YN | VARCHAR | No |
Indicates if there was erosion of the existing lead.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
35 | ICD_FAULTY_CONNCT_YN | VARCHAR | No |
Indicates if there was a faulty connector/header in the existing lead.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
36 | ICD_DOC_INFECTION_YN | VARCHAR | No |
Indicates if there was a documented infection of the existing lead as evidenced by positive microbiological cultures/smears or other microbiological evidence indicating infection.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
37 | ICD_PACING_ISSUE_YN | VARCHAR | No |
Indicates if there were pacing issues such as oversensing, undersensing, failure to pace, failure to capture with acceptable safety margin, or extracardiac stimulation.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
38 | ICD_OVERSENSE_YN | VARCHAR | No |
Indicates if the existing lead was functioning abnormally due to oversensing. Oversensing manifests as sensing of electrical signals not related to cardiac depolarization of the lead chamber that cannot be resolved acceptably by device reprogramming.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
39 | ICD_UNDERSENSE_YN | VARCHAR | No |
Indicates if the existing lead was functioning abnormally due to undersensing. Undersensing manifests as failure to sense appropriate cardiac depolarizations that cannot be resolved with reprogramming.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
40 | ICD_FAIL_TO_PACE_YN | VARCHAR | No |
Indicates if the existing lead was functioning abnormally because there was failure to pace. Failure to pace manifests as absence of pacemaker stimulation artifacts on electrocardiographic recordings despite rates below pacemaker programmed rate.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
41 | ICD_FAIL_SF_MRGN_YN | VARCHAR | No |
Indicates if the existing lead was functioning abnormally because there was failure to capture with acceptable safety margins. This manifests as a high pacing threshold that results in either intermittent failure to capture at maximal programmed output or excessive batter drain leading to premature battery exhaustion.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
42 | ICD_XTRACARD_STIM_YN | VARCHAR | No |
Indicates if the existing lead was functioning abnormally because there was extracardiac stimulation. This manifests as stimulation by the lead of non-cardiac structures such as the diaphragm, chest wall, or pectoral muscle.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
43 | ICD_DEFIB_ISSUES_YN | VARCHAR | No |
Indicates if the existing lead had defibrillation issues such as oversensing with or without shock/ATP, or failed shocks/inadequate Defibrillation Threshold (DFT) safety margins.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
44 | ICD_DFIB_OVRSNS_W_YN | VARCHAR | No |
Indicates if the existing lead had defibrillation problems due to oversensing with shock/antitachycardia pacing (ATP). This manifests as sensing of non-cardiac depolarization signals that met arrhythmia detection criteria and elicited programmed tachyarrhythmia therapy.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
45 | ICD_DFB_OVRSNS_WO_YN | VARCHAR | No |
Indicates if the existing lead had defibrillation issues due to oversensing without shock/antitachycardia pacing (ATP). This manifests as sensing of non-cardiac depolarization signals that did not meet arrhythmia detection criteria and do not elicit programmed tachyarrhythmia therapy.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
46 | ICD_DFB_FAIL_SHCK_YN | VARCHAR | No |
Indicates if the existing lead had defibrillation issues due to failed shocks or inadequate defibrillation threshold safety margins.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
47 | ICD_LD_INTG_ISSUE_YN | VARCHAR | No |
Indicates if the existing lead had abnormal function due to lead integrity issues.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
48 | ICD_LD_CNDCT_FAIL_YN | VARCHAR | No |
Indicates if the existing lead had abnormal function due to a lead integrity issue of conductor failure. Conductor failure manifests by high lead impedance either absolutely (above manufacturer's product specifications) or by a significant increase from previously stable chronic values.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
49 | ICD_LD_INSUL_FAIL_YN | VARCHAR | No |
Indicates if the existing lead had abnormal function due to a lead integrity issue of insulation failure. Insulation failure manifests as low lead impedance either absolutely (below manufacture's product specifications) or by a significant decrease from previously stable chronic values.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
50 | IMPLANTATION_TEMP_C_NAME | VARCHAR | No |
This item stores the tissue temperature at implantation.
May contain organization-specific values: Yes
No Entries Defined
51 | STORAGE_TEMP_C_NAME | VARCHAR | No |
This item stores the tissue storage temperature.
May contain organization-specific values: Yes
No Entries Defined
52 | IMPLANT_CLASS_C_NAME | VARCHAR | No |
Stores the class of the implant.
May contain organization-specific values: Yes
No Entries Defined
53 | PATIENT_REQUESTED_C_NAME | VARCHAR | No |
Stores if the implant was requested by the patient.
May contain organization-specific values: Yes
No Entries Defined
54 | IMPLANT_FIN_COMMENT | VARCHAR | No |
Stores the comment for the implant.
55 | CLINICAL_IND_C_NAME | VARCHAR | No |
Stores the clinical indication for the requested implant.
May contain organization-specific values: Yes
Category Entries:
None
56 | GUDID_REQUEST_C_NAME | VARCHAR | No |
This column stores the status of a request to the FDA's GUDID for information on this implant.
May contain organization-specific values: No
Category Entries:
Successful
Request failed - retrying
Preparing to send request
Waiting for response
Request failed - device not in GUDID
57 | GUDID_BRAND_NAME | VARCHAR | No |
This column stores the brand name obtained from Global Unique Device Identification Database (GUDID) for an implant.
58 | GUDID_VERSION_NUM | VARCHAR | No |
This column stores the version or model number obtained from GUDID for an implant.
59 | GUDID_COMPANY_NAME | VARCHAR | No |
This column stores the company name obtained from GUDID for an implant.
60 | GUDID_CONTAINS_LATEX_RUBBER | VARCHAR | No |
This column stores whether or not an implant is labeled as containing natural rubber latex or dry natural rubber according to GUDID. GUDID returns either a "true" or a "false" for this item. However, this is not a YN column as we want to be able to handle any new values that might be added for this field.
61 | GUDID_IMPLANT_DESCRIPTION | VARCHAR | No |
This column stores the implant Global Medical Device Nomenclature (GMDN) Preferred Term name obtained from GUDID for an implant.
62 | TISSUE_IDNT_CODE | VARCHAR | No |
This column stores the Distinct Identification Code for tissue implants.
63 | TISSUE_DIC_FLAGS | VARCHAR | No |
This column stores flag characters associated with the distinct identification code of a tissue implant.
64 | CONTAINER_LOT_NUMBER | VARCHAR | No |
This stores the container lot number for implants.
65 | CONTAINER_EXP_DATE | DATETIME | No |
This stores the container expiration date for implants.
66 | TISSUE_PLACED_IN_STORAGE_DTTM | DATETIME (UTC) | No |
This stores the instant the tissue was placed in storage.
67 | TISSUE_PLACED_IN_STORAGE_ID_PROV_NAME | VARCHAR | No |
The name of the service provider. This item may be hidden in a public view of the CLARITY_SER table.
68 | TISSUE_DONATION_VERIFIED_ID_PROV_NAME | VARCHAR | No |
The name of the service provider. This item may be hidden in a public view of the CLARITY_SER table.
69 | TISSUE_CULTURE_COLLECTED_BY_ID_PROV_NAME | VARCHAR | No |
The name of the service provider. This item may be hidden in a public view of the CLARITY_SER table.
70 | TISSUE_CULTURE_SENT_BY_ID_PROV_NAME | VARCHAR | No |
The name of the service provider. This item may be hidden in a public view of the CLARITY_SER table.
71 | TISSUE_REMOVED_FROM_STORAGE_ID_PROV_NAME | VARCHAR | No |
The name of the service provider. This item may be hidden in a public view of the CLARITY_SER table.
72 | TISSUE_REC_STORAGE_TEMPERATURE | NUMERIC | No |
This stores information regarding the recommended storage temperature.
73 | IMPLANT_APPROACH_C_NAME | VARCHAR | No |
The category ID for the approach taken for the implant/joint.
May contain organization-specific values: Yes
No Entries Defined
74 | FEMUR_MANUFACTURER_C_NAME | VARCHAR | No |
The femur manufacturer category ID for the implant.
May contain organization-specific values: Yes
75 | TIBIA_MANUFACTURER_C_NAME | VARCHAR | No |
The tibia manufacturer category ID for the implant.
The category values for this column were already listed for column: FEMUR_MANUFACTURER_C_NAME
76 | PREV_FEMUR_MANUFACTURER_C_NAME | VARCHAR | No |
The old femur prosthesis manufacturer category ID for the implant.
The category values for this column were already listed for column: FEMUR_MANUFACTURER_C_NAME
77 | PREV_TIBIA_MANUFACTURER_C_NAME | VARCHAR | No |
The old tibia prosthesis manufacturer category ID for the implant.
The category values for this column were already listed for column: FEMUR_MANUFACTURER_C_NAME
78 | CEMENT_USED_YN | VARCHAR | No |
Indicates whether cement was used for this implant. Y indicates cement was used. N indicates cement was not used. Null indicates cement usage was not assessed or is not applicable for this type of implant.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
79 | CEMENT_USED_FEMUR_YN | VARCHAR | No |
Indicates whether cement was used on the femur for this implant. Y indicates cement was used on the femur. N indicates cement was not used on the femur. Null indicates cement usage was not assessed or is not applicable for this type of implant.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
80 | CEMENT_USED_ACETABULUM_YN | VARCHAR | No |
Indicates whether cement was used on the acetabulum for this implant. Y indicates cement was used on the acetabulum. N indicates cement was not used on the acetabulum. Null indicates cement usage was not assessed or is not applicable for this type of implant.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
81 | CEMENT_USED_TIBIA_YN | VARCHAR | No |
Indicates whether cement was used on the tibia for this implant. Y indicates cement was used on the tibia. N indicates cement was not used on the tibia. Null indicates cement usage was not assessed or is not applicable for this type of implant.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
82 | CEMENT_USED_PATELLA_YN | VARCHAR | No |
Indicates whether cement was used on the patella for this implant. Y indicates cement was used on the patella. N indicates cement was not used on the patella. Null indicates cement usage was not assessed or is not applicable for this type of implant.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
83 | CEMENT_USED_OTHER_YN | VARCHAR | No |
Indicates whether cement was used on another prosthesis for this implant. Y indicates cement was used on another prosthesis. N indicates cement was not used on another prosthesis. Null indicates cement usage was not assessed or is not applicable for this type of implant.
The category values for this column were already listed for column: PRIMARY_DEVICE_YN
84 | CEMENT_TECHNIQUE_C_NAME | VARCHAR | No |
The cement application technique category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
85 | CEMENT_MIX_C_NAME | VARCHAR | No |
The cement mix category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
86 | CEMENT_MANUFACTURER_C_NAME | VARCHAR | No |
The cement manufacturer category ID for the implant.
The category values for this column were already listed for column: FEMUR_MANUFACTURER_C_NAME
87 | BONE_GRAFT_C_NAME | VARCHAR | No |
The bone graft type category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
88 | DEGEN_GLENOHUMERAL_C_NAME | VARCHAR | No |
The glenohumeral joint degeneration category ID for the implant. This describes the type of degeneration exhibited by the joint.
May contain organization-specific values: Yes
No Entries Defined
89 | AP_CONGRUENCE_C_NAME | VARCHAR | No |
The anteroposterior congruence category ID for the implant. This describes the congruence of the joint in the anteroposterior direction.
May contain organization-specific values: Yes
No Entries Defined
90 | CENTRIC_JOINT_C_NAME | VARCHAR | No |
The centric joint type category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
91 | POST_ECCENTRIC_CAPUT_C_NAME | VARCHAR | No |
The posteriorly eccentric caput category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
92 | ANT_ECCENTRIC_CAPUT_C_NAME | VARCHAR | No |
The anteriorly eccentric caput category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
93 | CRANIO_CONGRUENCE_C_NAME | VARCHAR | No |
The craniocaudal congruence category ID for the implant. This describes the congruence of the joint in the craniocaudal direction.
May contain organization-specific values: Yes
No Entries Defined
94 | SUP_ECCENTRIC_CAPUT_C_NAME | VARCHAR | No |
The superiorly eccentric caput category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
95 | JOINT_CONGRUENCE_C_NAME | VARCHAR | No |
The joint congruence category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
96 | GLENOID_COMPONENT_C_NAME | VARCHAR | No |
The glenoid component category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
97 | HUMERAL_COMPONENT_C_NAME | VARCHAR | No |
The humeral component category ID for the implant.
May contain organization-specific values: Yes
No Entries Defined
98 | CONTAINER_EXPIRATION_TIME | DATETIME (Local) | No |
This stores the container expiration time for implants.