FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2170335
·
Received July 20, 2011
Report
- Report Number
- 2124215-2011-09976
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 2, 2011
- 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
THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD WAS EXPLANTED AS IT DISLODGED DURING THE LEFT VENTRICULAR LEAD REVISION. NO ADVERSE PATIENT EFFECTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | N118| 4193| N119| H215| 4469| 0184| 4524| T165 |