FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL
MDR report key: 2153589
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06568
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- April 8, 2011
- Report Date
- July 18, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THREE MONTHS LATER, THE DEVICE WAS EXPLANTED AND REPLACED.
Additional Manufacturer Narrative · 1
TECHNICAL SERVICES RECOMMEDED MONTHLY INTENSIFIED FOLLOW UP APPOINTMENTS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WHICH WAS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW ADVISORY APRIL 2007 POPULATION PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON 4/5/2007, WAS SUSPECTED OF EXHIBITING THE ADVISORY BEHAVIOR. TO DATE THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.
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 | 78 YR | Hospitalization| L| R | 0185| 4518| MISMATCH| H219 |