FDA Adverse Event
Malfunction
Summary report: N
54 CM BIPOLAR LEAD
MDR report key: 3043021
·
Received March 7, 2013
Report
- Report Number
- 2183787-2013-00017
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Report Date
- March 4, 2013
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DTB
- PMA / PMN Number
- K925099
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
INFO WAS RECEIVED THAT DURING A F/U VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS. IN ADDITION, IMPEDANCE MEASUREMENTS HAD DECREASED FROM 773 OHMS TO 291 OHMS SINCE THE LAST MEASUREMENT. A DECISION WAS MADE TO REPLACE THIS LEAD. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS CUT THROUGH AND DISCARDED. ACCEPTABLE MEASUREMENTS WERE OBTAINED WITH THE REPLACEMENT LEAD. NO ADVERSE PT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98373 | 54 CM BIPOLAR LEAD | BIPOLAR LEAD | DTB | GREATBATCH MEDICAL | 511212 | W2207385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |