FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3041060
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01112
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 11, 2013
- Report Date
- January 11, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
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 RECENTLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WITH OVERSENSING WHICH RESULTED IN AN INAPPROPRIATE SHOCK. IT WAS DETERMINED THAT THE LEAD DID NOT HAVE ENOUGH SLACK AND DISLODGED. SURGICAL INTERVENTION WAS PERFORMED AND THIS LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143897 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 310 MO | Hospitalization| L| R | 0295| E162| 4470 |