FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2053220
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04007
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 4, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO FURTHER INFORMATION IS EXPECTED REGARDING THIS EVENT, THEREFORE THIS INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR LEAD DISLODGED. IT WAS THOUGHT THIS LEAD DISLODGED DURING THE REMOVAL OF THE LEAD FROM THE EXTERNAL PACEMAKER SYSTEM. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SUCCESSFULLY REPOSITIONED. NO 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 | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |