FINELINE II
Report
- Report Number
- 2124215-2013-01354
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- January 17, 2013
- Report Date
- March 26, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
UPON RECEIPT OF FURTHER INFORMATION, THIS EVENT WILL BE UPDATED.
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD WAS HOSPITALIZED. TELEMETRY REVEALED LOSS OF CAPTURE RESULTING IN A PRESYNCOPAL EPISODE. INTERROGATION REVEALED AN INTERMITTENT LEAD FRACTURE. A REVISION PROCEDURE IS INTENDED. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.
SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED.
ADDITIONAL INFORMATION WAS OBTAINED. THIS LEAD HAD ALSO DISPLAYED NOISE AND INCREASED THRESHOLD MEASUREMENTS. WHEN THE REVISION HAD BEEN PERFORMED, THERE WAS NO VISUAL OBSERVATION OF A LEAD FRACTURE. THE PATIENT WITH THIS LEAD IS NOT PACEMAKER DEPENDENT. REPROGRAMMING THE DEVICE TO MAXIMUM OUTPUTS HAD NOT RESOLVED THE ISSUE. UPON OPENING THE POCKET, NO VISUAL INSPECTION OF EXPOSED SECTION OF THE LEAD DID NOT REVEAL ANY LEAD FRACTURE. THE DEVICE WAS ALSO REPLACED AS IT HAD BEEN IMPLANTED APPROXIMATELY SEVEN YEARS. THIS LEAD WAS SURGICALLY ABANDONED AND THERE WAS NO INTENDED DEVICE RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147346 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R |