FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2173182
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10838
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 16, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED IMPEDANCES OF GREATER THAN 2,500 OHMS. IT WAS NOTED THAT THE PATIENT HAD BEEN NON-COMPLIANT WITH FOLLOW-UPS AND WHEN THEY PRESENTED TO THE CLINIC, THEIR DEVICE HAD BEEN PROGRAMMED SUB-THRESHOLD. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. A LEAD FRACTURE WAS SUSPECTED. 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 | 90 YR | Required Intervention | S601| 1190| 4137| 4457 |