FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 2171359
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10046
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 3, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS IN SERVICE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP APPOINTMENT IT WAS NOTED THAT THIS ATRIAL LEAD HAD IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS FROM APPROXIMATELY THREE MONTHS AGO. HOWEVER, TESTING IMPEDANCES IN THE CLINIC WERE NORMAL. TECHNICAL SERVICES DISCUSSED CHECKING THE DAILY MEASUREMENTS FOR OTHER OUT OF RANGE MEASUREMENTS AND DISCUSSED PERFORMING ISOMETRICS FOR POTENTIAL LEAD ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | T125| 4473| T165| 0184 |