FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2161548
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-06818
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 15, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID EXHIBIT LOW SHOCK IMPEDANCE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THE LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT THERE WAS NO PLAN FOR ANY ACTION TO BE TAKEN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | 4470| 0185| 4555| N119 |