FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1953763
·
Received January 10, 2011
Report
- Report Number
- 2124215-2010-24000
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 12, 2010
- Report Date
- December 8, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD DEVELOPED AN INFECTION. AT THIS TIME, IT IS UNKNOWN IF THE LEADS WERE EXPLANTED AS A RESULT OF THE INFECTION. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS CHANGED OUT TO A COMPETITOR'S PRODUCT. THE FIELD REPRESENTATIVE HAS NO FURTHER INFORMATION REGARDING THE CHANGE OUT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention | 0184| MISMATCH| 4470| H177 |