FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1945565
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-19924
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 11, 2010
- Report Date
- October 11, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECIEVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING NOISE AND IMPEDANCE MEASUREMENTS GREATER THAN 2500 DUE TO A FRACTURE. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPLACED WITHOUT FURTHER INCIDENT. IT WAS NOTED THAT THE PATIENT IS A SKYDIVER, BUT HAD NOT BEEN SKYDIVING RECENTLY. 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 | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | 4458| 4469| 4087| 1297 |