FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 1970200
·
Received January 25, 2011
Report
- Report Number
- 2124215-2011-01149
- Event Type
- Malfunction
- Date Received
- January 25, 2011
- Date of Event
- December 29, 2010
- Report Date
- December 29, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL SERVICES DISCUSSED HOW LONGEVITY IS EFFECTED BY THERAPY AND DEVICE PROGRAMMING. TECHNICAL SERVICES REFERRED THE PATIENT TO THEIR PHYSICIAN. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD RECEIVED FOUR SHOCKS SINCE THE DEVICE WAS IMPLANTED. THE PATIENT REPORTED THEY PASSED OUT PRIOR TO EACH SHOCK BEING DELIVERED. THE PATIENT EXPRESSED CONCERN THAT THE BATTERY WAS DEPLETING PREMATURELY DUE TO THERAPY BEING DELIVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | (B)(4)| (B)(4)| (B)(4)| (B)(4) |