FINELINE II
Report
- Report Number
- 2124215-2011-00926
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 28, 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
THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED 26.5 CENTIMETERS (CM) FROM THE TERMINAL PIN; THE PROXIMAL SEGMENT ONLY WAS RETURNED. A SETSCREW MARK WAS NOTED ON THE TERMINAL PIN AND RING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY OF THE RETURNED LEAD SEGMENT. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASED SENSING AND LOSS OF CAPTURE. A REVISION PROCEDURE WAS THEREFORE PERFORMED. AN ATTEMPT WAS MADE TO EXTRACT THE LEAD; HOWEVER, WAS UNSUCCESSFUL AND THE TIP OF THE LEAD REMAINS IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
THE LEAD WAS LATER RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | T167| 4471| 0184| E110| 0157| 4469| A155 |