FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 3211555
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-09824
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 6, 2013
- Report Date
- May 6, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT ATRIAL (RA) LEAD HAS TWIDDLER'S SYNDROME. THIS LEAD WAS NOTED TO HAVE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308695 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | 4479| K063| 1290| 4135| 4456 |