FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2052600
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04044
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 25, 2011
- Report Date
- February 25, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO DISLODGEMENT. PRIOR TO THE REVISION PROCEDURE THE LEAD EXHIBITED LOSS OF CAPTURE IN BIPOLAR AND UNIPOLAR CONFIGURATIONS AT MAXIMUM OUTPUT MEASUREMENTS. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. 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 | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization| L| R | 4137| 1194| 4088| S601| 4457 |