ENDOTAK RELIANCE SG
Report
- Report Number
- 2124215-2025-68800
- Event Type
- Malfunction
- Date Received
- September 29, 2025
- Date of Event
- September 15, 2025
- Report Date
- December 11, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526531156
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
THIS REPORT IS BEING SENT TO PROVIDE NEW INFORMATION IN SECTION B5 (EVENT DESCRIPTION).
THIS REPORT IS BEING SENT TO PROVIDE NEW INFORMATION IN SECTION B5 (EVENT DESCRIPTION). THIS REPORT IS BEING SENT TO PROVIDE NEW INFORMATION IN SECTIONS H6 (EVALUATION CONCLUSION CODES) AND H11 (ADDITIONAL MFR NARRATIVE). THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC AND PHYSICAL ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION/DATA DETERMINED THAT THE OBSERVED GRADUAL RISE IN LVSI MEASUREMENTS WAS LIKELY ASSOCIATED WITH CALCIFICATION, AS THERE WAS NO CONCLUSIVE EVIDENCE OF COMPROMISED PHYSICAL OR ELECTRICAL INTEGRITY OF THE LEAD. THIS CONDITION MAY DEVELOP OVER TIME AND CAN BE REFLECTED IN A GRADUAL AND SUSTAINED INCREASE IN SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC ISSUED A FIELD SAFETY NOTICE TO PHYSICIANS IN JULY 2025 REGARDING THE POTENTIAL FOR RELIANCE DEFIBRILLATION LEADS WITH EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) COATING TO EXHIBIT A PATTERN OF GRADUALLY INCREASING LVSI MEASUREMENTS DUE TO CALCIFICATION, WHICH MAY RESULT IN ELEVATED HIGH VOLTAGE SHOCK IMPEDANCE (HVSI) MEASUREMENTS AND REDUCED SHOCK EFFICACY.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS EXHIBITED GRADUALLY INCREASING SHOCK IMPEDANCE MEASUREMENTS, WITH THE MOST RECENT VALUE BEING OUT-OF-RANGE (140 OHMS). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED THAT THIS LEAD IMPEDANCE HAD BEEN STABLE UNTIL 2020, WHERE IT BEGAN GRADUALLY INCREASING. AS THE SHOCK IMPEDANCE HAD NOT EXCEEDED 150 OHMS, TS RECOMMENDED CONTINUING WITH MONITORING WITH ALL SHOCKS PROGRAMMED TO THE MAXIMUM ENERGY (41 J), IF CLINICALLY APPROPRIATE. AT THIS TIME, THE RV LEAD REMAINS IMPLANTED AND IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS EXHIBITED GRADUALLY INCREASING SHOCK IMPEDANCE MEASUREMENTS, WITH THE MOST RECENT VALUE BEING OUT-OF-RANGE (140 OHMS). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND IS PENDING A DATA REVIEW PRIOR TO A POTENTIAL LEAD REVISION PROCEDURE. AT THIS TIME, THE RV LEAD REMAINS IMPLANTED AND IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS EXHIBITED GRADUALLY INCREASING SHOCK IMPEDANCE MEASUREMENTS, WITH THE MOST RECENT VALUE BEING OUT-OF-RANGE (140 OHMS). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED THAT THIS LEAD IMPEDANCE HAD BEEN STABLE UNTIL 2020, WHERE IT BEGAN GRADUALLY INCREASING. AS THE SHOCK IMPEDANCE HAD NOT EXCEEDED 150 OHMS, TS RECOMMENDED CONTINUING WITH MONITORING WITH ALL SHOCKS PROGRAMMED TO THE MAXIMUM ENERGY (41 J), IF CLINICALLY APPROPRIATE. AT THIS TIME, THE RV LEAD REMAINS IMPLANTED AND IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1944171 | ENDOTAK RELIANCE SG | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | 0181 | 323671 | 00802526531156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |