FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2170341
·
Received July 20, 2011
Report
- Report Number
- 2124215-2011-11280
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- June 1, 2011
- Report Date
- July 1, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION PROVIDED THAT THE LEAD WILL NOT BE RETURNED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE HOSPITAL FEELING UNWELL. HIGH IMPEDANCES AND LOSS OF CAPTURE WERE OBSERVED IN THE BIPOLAR CONFIGURATION. THE CONFIGURATION WAS THEN CHANGED TO UNIPOLAR AND NORMAL IMPEDANCE MEASUREMENTS WERE OBSERVED. THE PHYSICIAN SUSPECTED A LEAD FRACTURE. SUBSEQUENTLY, A REVISION PROCEDURE TOOK PLACE TO ADD A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |