FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3043102
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-01720
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- 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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THE NOISE WAS SENSED WHICH RESULTED IN INAPPROPRIATE SHOCKS. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147485 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | E160| 0292| 0148| T175 |