FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1945534
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-19869
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 11, 2010
- Report Date
- October 11, 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
IF NEW INFORMATION IS RECEIVED, THE EVENT WILL BE REOPENED AND FURTHER UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ENTIRE IMPLANTED SYSTEM WAS REMOVED DUE TO INFECTION; IMPLANT DURATION APPROXIMATELY 7 MONTHS. NO ADVERSE PATIENT EFFECTS REPORTED AND NONE OF THE REMOVED PRODUCT, WILL BE RETURNED FOR POST MARKET EVALUATION.
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 |