FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2153539
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06262
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 6, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. 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 WAS EXPLANTED DUE TO AN INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | 4456| 4473| 4457| 1298| 4472 |