FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1950752
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22564
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 18, 2010
- Report Date
- November 18, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS REPOSITIONED, REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT, THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD EXPERIENCED AN INAPPROPRIATE SHOCK. INTERROGATION REVEALED NOISE CAUSING OVERSENSING WITH TEN BEAT PACING INHIBITION. THE NOISE COULD BE REPRODUCED. IT WAS THOUGHT THERE WAS A LEAD PERFORATION. A REVISION PROCEDURE WAS PERFORMED, THIS LEAD WAS REPOSITIONED. NO FURTHER ADVERSE PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |