Device product
Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.
Z-2147-2014
Product summary
- Event
- Event 68700
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21
- Official record key
device-enforcement:Z-2147-2014
Official wording
Reason: A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.
Code information: Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.
Distribution pattern: Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
Derived failure modes
-
Unknown
A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.