FDA Adverse Event
Malfunction
Summary report: N
54 CM BIPOLAR LEAD
MDR report key: 3980216
·
Received June 5, 2014
Report
- Report Number
- 2183787-2014-00073
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- April 30, 2014
- Report Date
- May 21, 2014
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DTB
- PMA / PMN Number
- P130012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PLUGGED INTO THE DEVICE'S RIGHT VENTRICULAR (RV) PORT. THIS LEAD EXHIBITED POOR MORPHOLOGY. HENCE THE PHYSICIAN DECIDED TO SURGICALLY ABANDON THIS LV LEAD AND REINSERT AN OLD CHRONIC RIGHT VENTRICULAR (RV) PACE/SENSE LEAD THAT WAS WORKING WELL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD IS NO LONGER IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330473 | 54 CM BIPOLAR LEAD | BIPOLAR LEAD | DTB | GREATBATCH MEDICAL | 511212 | W2080853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |