FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3212933
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09992
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- March 14, 2013
- Report Date
- June 10, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH SHOCK IMPEDANCES WERE DETECTED ON THIS RIGHT VENTRICULAR (RV) LEAD WHICH WAS IDENTIFIED THROUGH THE PATIENT'S REMOTE HOME MONITORING SYSTEM. AS OF TODAY, ALL AVAILABLE INFORMATION INDICATES THAT THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313668 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | 0180| 4135| E110 |