FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2171553
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10260
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 7, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS ABANDONED, THEREFORE BOSTON SCIENTIFIC CRM WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO HIGH IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THE LEAD HAD INAPPROPRIATE DETECTIONS DUE TO NOISE. IT WAS NOTED THAT THE LEAD WAS FRACTURED. NO ADVERSE PATIENT EFFECTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | 1298| S606| 4136| 4469| 4470 |