FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 3053588
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05200
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- PHYSICIAN
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 DURING THE PACEMAKER REPLACEMENT PROCEDURE, WHEN THIS RIGHT ATRIAL (RA) LEAD WAS CONNECTED TO THE HEADER BLOOD WAS OBSERVED. WHEN TESTED, THE LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE LEAD WAS REPROGRAMMED TO A UNIPOLAR CONFIGURATION AND IMPEDANCES DECREASED TO AN ACCEPTABLE RANGE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156494 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | 4473| K063| 4474| 1290 |