FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL
MDR report key: 2171547
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10309
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE PRODUCT IS RETURNED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR DISPLAYED A BATTERY STATUS OF END OF LIFE. THE MONITORING VOLTAGE WAS 2.18 AND THE CHARGE TIME WAS 36.1 SECONDS. THE DEVICE WAS EXPLANTED AND THERE WAS A CONCERN ABOUT THE BATTERY LONGEVITY. THIS DEVICE IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY NOTIFICATION ISSUED IN 2007. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R | H175| 0184| 4087| 4524| N118 |