FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1950455
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22365
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- August 4, 2010
- Report Date
- November 16, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED SYSTEM WAS NOT RETURNED TO BOSTON SCIENTIFIC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, RIGHT VENTRICULAR DEFIBRILLATION LEAD, AND ATRIAL LEAD WERE EXPLANTED DUE TO INFECTION. APPROXIMATELY ONE MONTH LATER, A NEW PACING SYSTEM WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |