FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 1771304
·
Received July 27, 2010
Report
- Report Number
- 2124215-2010-12353
- Event Type
- Malfunction
- Date Received
- July 27, 2010
- Date of Event
- June 8, 2010
- Report Date
- July 16, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- PMA / PMN Number
- P010012
- Removal / Correction Number
- Z-0863-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
REQUESTS WERE MADE FOR PRODUCT RETURN. INFORMATION SUGGEST THESE PRODUCTS REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED SHOCK IMPEDANCES <20 OHMS. THERE WAS INQUIRIES ON TROUBLESHOOTING AND EXPLANTING THE LEAD. 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 | H210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | 4548| 4470| 0184| H210 |