FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2170924
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10081
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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 THIS ATRIAL LEAD WHEN PROGRAMMED IN BIPOLAR CONFIGURATION HAD IMPEDANCES GREATER THAN 2500 OHMS, NO CAPTURE AND NOISE. HOWEVER, WHEN PROGRAMMED TO UNIPOLAR CONFIGURATION HAD IMPEDANCES OF 300 OHMS, GOOD CAPTURE, THRESHOLDS AND NO NOISE. THE LEAD WAS SURGICALLY ABANDONED. 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 | 4473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention | 1297| 4459| 4473 |