FDA Adverse Event
Malfunction
Summary report: N
RELIANCE 4-FRONT
MDR report key: 22992724
·
Received September 8, 2025
Report
- Report Number
- 2124215-2025-62873
- Event Type
- Malfunction
- Date Received
- September 8, 2025
- Date of Event
- January 1, 2020
- Report Date
- September 8, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVY
- UDI-DI
- 00802526519017
- PMA / PMN Number
- P910073/S145
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP THE SHOCK LEAD IMPEDANCES MEASURED 121 OHMS. TECHNICAL SERVICES (TS) REVIEWED LEAD TRENDS, AND IT APPEARS THERE IS A GRADUAL INCREASE WITH CURRENT VALUES IN BETWEEN 100-125 OHMS. TS PROVIDED TROUBLESHOOTING OPTIONS. AT TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2068321 | RELIANCE 4-FRONT | IMPLANTABLE LEAD | NVY | BOSTON SCIENTIFIC CORPORATION | 0692 | 515139 | 00802526519017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |