FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 1952143
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23375
- Event Type
- Malfunction
- Date Received
- January 7, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 1, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE OR SHOULD THE DEVICE BE RETURNED AND ANALYSIS PERFORMED, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE REVEALED ELECTIVE REPLACEMENT INDICATORS AFTER BEING IMPLANTED THREE YEARS. THERE WAS CONCERN THAT THIS DEVICE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. A REPLACEMENT PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | 4543| H177| 0158| 4087 |