FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 2173276
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-12198
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 12, 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
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD A COMPROMISED LOW-VOLTAGE CAPACITOR THAT DID NOT MEET DESIGN SPECIFICATION. DESPITE THIS COMPROMISED CAPACITOR, CURRENT LEAKAGE WAS NOT SUFFICIENT TO ADVERSELY IMPACT DEVICE LONGEVITY. NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS WERE VERIFIED DURING TESTING.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DID NOT PASS A PORTION OF THE RETURNED PRODUCTS TESTING, SUGGESTING A POSSIBLE PERFORMANCE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | 1581| H170| MISMATCH |