FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1944934
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-19665
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 5, 2010
- Report Date
- October 5, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REQUEST HAS BEEN MADE TO HAVE THESE PRODUCTS RETURNED TO BOSTON SCIENTIFIC. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TRANSVENOUS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXPLANTED AFTER THE PATIENT DEVELOPED A SYSTEM INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other| R | 0158| E102 |