FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2172858
·
Received July 22, 2011
Report
- Report Number
- 2124215-2011-09928
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. FURTHER FOLLOW UP WILL BE PERFORMED AT THE NEXT SCHEDULED FOLLOW UP VISIT.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. NO NOISE WAS REVEALED. INTERROGATION REVEALED ALL OTHER LEAD MEASUREMENTS ARE WITHIN NORMAL LIMITS. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THIS ISSUE AND SUGGESTED A REVIEW OF THE DAILY MEASUREMENTS. THE PATIENT WITH THIS LEAD HAS CARDIOMYOPATHY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 150 MO | 0171 |