FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2052614
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03509
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD REMAINS IMPLANTED AND THUS NO ANALYSIS WILL BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST OPERATIVE FOLLOW UP SHOWED NORMAL MEASURES ON THIS RIGHT VENTRICULAR (RV) LEAD, BUT AN X-RAY REVEALED A LEAD DISLODGEMENT. THIS RV LEAD WAS REPOSITIONED AND REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AFTER REPOSITIONING THIS LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |