FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1951529
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-23290
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 23, 2010
- Report Date
- November 23, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THIS RIGHT ATRIAL (RA) LEAD WILL BE EXPLANTED DUE TO AN INFECTION AND POCKET EROSION. IT WAS NOTED THAT THE HEADER OF THE DEVICE WAS EXPOSED AND THE PATIENT WAS PACEMAKER DEPENDENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | 4047| 4470| N119| 4968| 4046| 0185| 0184 |