Device product
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Z-1979-2013
Product summary
- Event
- Event 65798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 (4 devices were implanted and are not part of this action)
- Official record key
device-enforcement:Z-1979-2013
Official wording
Reason: Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufactu
Code information: Serial # 108063
Distribution pattern: US distribution in the state of Tennessee.
Derived failure modes
-
Unknown
Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufactu