FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2151276
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06131
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 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
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED A BACTERIA GROWTH ON THE VALVE, THEREFORE THE ENTIRE PACING SYSTEM WAS REMOVED FROM SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS NOTED THAT THE PATIENT WILL LIKELY NOT RECEIVE A NEW DEVICE AS THEY WERE NOT PACEMAKER DEPENDENT.
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 | 86 YR | Hospitalization| L| R | S603| 4469| 4137 |