ENDOTAK RELIANCE SG
Report
- Report Number
- 2124215-2022-19040
- Event Type
- Injury
- Date Received
- June 1, 2022
- Date of Event
- April 21, 2022
- Report Date
- June 5, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVY
- PMA / PMN Number
- P910073/S077
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IMPLANTED, IN-SERVICE AND HAS NOT BEEN RETURNED. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, THE PRIMARY REPORTED OBSERVATION IS ADDRESSED IN PRODUCT LABELING (I.E. INSTRUCTIONS FOR USE). ANALYSIS DETERMINED THAT THE HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS ARE A KNOWN INHERENT RISK WITH USE OF THIS PRODUCT, BUT ROOT CAUSE DETERMINATION IS ONGOING. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.
IT WAS REPORTED THAT A RED ALERT WAS RECORDED DUE TO CLIMBING HIGH SHOCK IMPEDANCE MEASUREMENTS THAT REACHED 125 OHMS. TECHNICAL SERVICES DISCUSSED THAT A COMMANDED SHOCK SHOULD BE PERFORMED IF THE RANGE GO AS HIGH AS 135 - 145 OHMS. HOWEVER, BECAUSE THE PATIENT IS ELDERLY AND HAS NEVER REQUIRED TACHY THERAPY, INCLUDING ANTI-TACHYCARDIA PACING, IT WAS BELIEVED RELUCTANT TO BRING THE PATIENT FOR TESTING. FURTHER INFORMATION WAS RECEIVED CONFIRMING NO COMMANDED SHOCKS WERE PERFORMED AND THE PATIENT WILL CONTINUE TO BE MONITORED. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT A RED ALERT WAS RECORDED DUE TO CLIMBING HIGH SHOCK IMPEDANCE MEASUREMENTS THAT REACHED 125 OHMS. TECHNICAL SERVICES DISCUSSED THAT A COMMANDED SHOCK SHOULD BE PERFORMED IF THE RANGE GO AS HIGH AS 135 - 145 OHMS. HOWEVER, BECAUSE THE PATIENT IS ELDERLY AND HAS NEVER REQUIRED TACHY THERAPY, INCLUDING ANTI-TACHYCARDIA PACING, IT WAS BELIEVED RELUCTANT TO BRING THE PATIENT FOR TESTING. FURTHER INFORMATION WAS RECEIVED CONFIRMING NO COMMANDED SHOCKS WERE PERFORMED AND THE PATIENT WILL CONTINUE TO BE MONITORED. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING A SYNC SHOCK WAS PERFORMED, AND THE IMPEDANCE WAS 146 OHMS. SUBSEQUENTLY, THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND AND REPLACED, AND THE DEVICE WAS EXPLANTED AND REPLACED, DUE TO A PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT A RED ALERT WAS RECORDED DUE TO CLIMBING HIGH SHOCK IMPEDANCE MEASUREMENTS THAT REACHED 125 OHMS. TECHNICAL SERVICES DISCUSSED THAT A COMMANDED SHOCK SHOULD BE PERFORMED IF THE RANGE GO AS HIGH AS 135 - 145 OHMS. HOWEVER, BECAUSE THE PATIENT IS ELDERLY AND HAS NEVER REQUIRED TACHY THERAPY, INCLUDING ANTI-TACHYCARDIA PACING, IT WAS BELIEVED RELUCTANT TO BRING THE PATIENT FOR TESTING. FURTHER INFORMATION WAS RECEIVED CONFIRMING NO COMMANDED SHOCKS WERE PERFORMED AND THE PATIENT WILL CONTINUE TO BE MONITORED. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING A SYNC SHOCK WAS PERFORMED, AND THE IMPEDANCE WAS 146 OHMS. SUBSEQUENTLY, THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED, AND THE DEVICE WAS EXPLANTED AND REPLACED, DUE TO A PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 599588 | ENDOTAK RELIANCE SG | IMPLANTABLE LEAD | NVY | BOSTON SCIENTIFIC CORPORATION | 0293 | 112702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Male | Hospitalization| R |