FINELINE II
Report
- Report Number
- 2124215-2010-24443
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 21, 2010
- 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
OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS BEING REPOSITIONED DUE TO DISLODGEMENT. A REVISION PROCEDURE WAS SCHEDULED TO REPOSITION THE LEADS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS NON-COMPLIANT WITH THE PHYSICIAN'S RECOMMENDATIONS TO KEEP HIS LEFT ARM IN A SLING, NOR WOULD THE PATIENT KEEP HIS ARM AT HIS SIDE. THE PATIENT ALSO ADMITTED THAT HE HAD BEEN IN A FIGHT WITH ANOTHER MAN SHORTLY AFTER LEAVING THE HOSPITAL. THESE ISSUES MOST LIKELY ATTRIBUTED TO THE LEADS DISLODGING. A REVISION PROCEDURE WAS PERFORMED AND THE LEADS WERE SUCCESSFULLY REPOSITIONED.
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 | 47 YR | Required Intervention | E110| 0184| 4469 |