FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1950438
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22482
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 15, 2010
- Report Date
- November 15, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE. THE LEAD ALSO EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. IT WAS NOTED THAT THE PHYSICIAN FELT THAT THE PATIENT DID NOT REQUIRE ATRIAL PACING SUPPORT. 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 | 4479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | 4479| 1861| 0147 |