FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3212897
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10247
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- May 23, 2013
- Report Date
- June 11, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. A FOLLOW UP VISIT WAS PERFORMED AND NORMAL MEASUREMENTS WERE OBTAINED. A DECISION WAS MADE TO FURTHER MONITOR THIS SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312975 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |