FDA Adverse Event
Malfunction
Summary report: N
ENERGEN
MDR report key: 2913704
·
Received January 14, 2013
Report
- Report Number
- 2124215-2013-00392
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- April 16, 2012
- Report Date
- December 21, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RV LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WITH AN ATTEMPTED N141 (REMOVED) DEVICE AND AGAIN WITH THIS NEW N141 DEVICE. THIS DEVICE REMAINED IMPLANTED AND LATER THE RV LEAD WAS REMOVED FOR A FRACTURE. A NEW RV LEAD WAS IMPLANTED WHICH DISPLAYED NORMAL SHOCK IMPEDANCE MEASUREMENTS. THE PATIENT LATER DEVELOPED A POCKET HEMATOMA AND THE POCKET WAS DEBRIDED. CULTURES WERE TAKEN AND WERE NEGATIVE FOR INFECTION. THE DEVICE/SYSTEM REMAIN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20445 | ENERGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | N141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | 4470| N141| 4047| H170| 0185 |