FDA Adverse Event
Malfunction
Summary report: N
54 CM BIPOLAR LEAD
MDR report key: 2802542
·
Received October 19, 2012
Report
- Report Number
- 2183787-2012-00080
- Event Type
- Malfunction
- Date Received
- October 19, 2012
- Report Date
- October 16, 2012
- 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
INFORMATION WAS RECEIVED THAT THE PT WITH THIS LEFT VENTRICULAR (LV) LEAD WAS NOT FEELING WELL. THRESHOLD MEASUREMENTS WERE NOTED AT 2.3V AT 2MS. DURING AN UPGRADE PROCEDURE THE LV LEAD WAS SURGICALLY ABANDONED. TO DATE, THERE WERE NO REPORTS OF ADVERSE PT EFFECTS DUE TO THIS PROCEDURE. THERE WERE NO MALFUNCTION ASSOCIATED WITH THE DEVICE SYSTEM THAT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 54 CM BIPOLAR LEAD | BIPOLAR LEAD | DTB | GREATBATCH MEDICAL | 511212 | W51707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |