FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 2173622
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-11048
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 20, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE. 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 A FOLLOW UP VISIT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD ATRIAL ELECTROGRAMS THAT WERE THE SAME AS THE VENTRICULAR ELECTROGRAMS. DURING ATRIAL THRESHOLD TESTING OF THE RIGHT ATRIAL (RA) LEAD, IT RESULTED IN VENTRICULAR PACING. IT WAS CONFIRMED THAT THE RA LEAD HAD DISLODGED. IN ADDITION, INAPPROPRIATE SHOCKS WERE DELIVERED DUE TO DISLODGEMENT. THE DEVICE WAS REPROGRAMMED TO VVI. 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 | 4480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0175| T165| 4480 |