FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 3212435
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09218
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 29, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED, THEREFORE, ANALYSIS CANNOT BE PERFORMED TO CONFIRM OR DENY THE REPORTED CLINICAL ALLEGATION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION OF THIS CHRONIC RIGHT VENTRICULAR LEAD REVEALED AN ABRUPT HIGH OUT OF RANGE IMPEDANCE MEASUREMENT APPROXIMATELY TWO MONTHS EARLIER. A POSSIBLE LEAD FRACTURE WAS SUSPECTED. AS THE PATIENT WITH THIS LEAD IS PACEMAKER DEPENDENT WITH AN ESCAPE RHYTHM AND LONG PAUSES, A REVISION PROCEDURE WILL BE PERFORMED. DURING THE INTENDED REVISION, THIS LEAD WILL BE SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT SYMPTOMS WERE EXPERIENCED AS A RESULT OF THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314321 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |