INGEVITY+
Report
- Report Number
- 2124215-2024-55928
- Event Type
- Injury
- Date Received
- September 6, 2024
- Date of Event
- August 14, 2024
- Report Date
- September 13, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526604577
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. CORRECTION TO D4: THE EXPLANTED LEAD WAS 7841/1382954 (4470/ 902134 IS THE CURRENTLY ACTIVE LEAD).
THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED AND REPLACED DUE TO LOSS OF ATRIAL PACING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE RIGHT ATRIAL (RA) LEAD REVISION, THERE WERE NO ISSUES NOTED WITH THE LEAD-TO-HEADER CONNECTIONS. ADDITIONALLY, THERE WAS NO EVIDENCE OF ASYSTOLE GREATER THAN TWO SECONDS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED AND REPLACED DUE TO LOSS OF ATRIAL PACING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1235899 | INGEVITY+ | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | NVN | BOSTON SCIENTIFIC CORPORATION | 7841 | 1382954 | 00802526604577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |