FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1952092
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23441
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 1, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS RV LEAD WAS CAPPED AND ABANDONED, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO INFECTION. THE INFECTION WAS ONLY ON THE LEFT SIDE WHERE THIS RV LEAD WAS IMPLANTED. THE ASSOCIATED DEVICE WAS IMPLANTED ON THE RIGHT SIDE, SO THEREFORE REMAINS IN SERVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
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 |