FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE SG
MDR report key: 13138451
·
Received January 1, 2022
Report
- Report Number
- 2124215-2021-38217
- Event Type
- Malfunction
- Date Received
- January 1, 2022
- Date of Event
- November 10, 2021
- Report Date
- September 9, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVY
- UDI-DI
- 00802526431371
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD A SHOCK IMPEDANCE MEASUREMENT OF 70 OHMS AT IMPLANT AND GRADUALLY INCREASED TO THE HIGH OUT OF RANGE MEASUREMENTS IN THE 123-127 OHMS RANGE, WHICH SUGGESTS THE CAUSE WAS LEAD-RELATED. THRESHOLDS AND SENSING WERE FINE. THIS RV LEAD REMAINS IN SERVICE AND WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 926680 | ENDOTAK RELIANCE SG | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | BOSTON SCIENTIFIC CORPORATION | 0282 | 328650 | 00802526431371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female |