FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1944959
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-19570
- 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 WAS MADE FOR PRODUCT RETURN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), DEFIBRILLATION, TRANSVENOUS, AND CORONARY SINUS LEADS DEVELOPED AND INFECTION. THE DEVICE WAS REPORTED TO BE EXPLANTED AND A NON-BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. THE HEALTH CARE PROVIDER DID NOT KNOW IF THE LEADS WERE EXPLANTED AS WELL. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | 0185| 4554| 4470| T180 |