FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 2052742
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03575
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- May 1, 2010
- Report Date
- February 24, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ASSOCIATED DEVICE WAS REPROGRAMMED FROM DDD MODE TO AAI. THE LEAD REMAINS IMPLANTED. 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 BACK IN (B)(6) 2010, THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DISLODGEMENT DID NOT AFFECT PACING IN THE VENTRICLE AS THE PATIENT HAS SICK SINUS SYNDROME WITH GOOD AV CONDUCTION.
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 | Other |