FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE G
MDR report key: 25096626
·
Received May 6, 2026
Report
- Report Number
- 2124215-2026-24545
- Event Type
- Malfunction
- Date Received
- May 6, 2026
- Date of Event
- April 17, 2026
- Report Date
- May 11, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526422065
- PMA / PMN Number
- P910073/S043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE REMAINS IN SERVICE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS HIGHER THAN 200 OMHS. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED FOLLOW UP. THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508713 | ENDOTAK RELIANCE G | IMPLANTABLE LEAD | LWS | BOSTON SCIENTIFIC CORPORATION | 0184 | 314431 | 00802526422065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female |