FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3212509
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09900
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 23, 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 THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A LOW OUT OF RANGE SHOCK IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE LEAD CONTINUES TO REMAIN IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312212 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | 4542| 4470| 0185| T167| N161 |