FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3213666
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10516
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 21, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- 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 WAS INVOLVED IN A LEAD REVISION DUE TO LEAD DISLODGEMENT A FEW DAYS POST IMPLANT. THIS RV LEAD EXHIBITED HIGH PACING THRESHOLD AND NOISE THAT HAD CAUSED INAPPROPRIATE SHOCK. THE PATIENT WAS HOSPITALIZED AND THE RV LEAD WAS REPOSITIONED SUCCESSFULLY. THIS RV LEAD REMAINED IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314232 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |