FDA Adverse Event
Malfunction
Summary report: N
54 CM UNIPOLAR LEAD
MDR report key: 3243126
·
Received July 18, 2013
Report
- Report Number
- 2183787-2013-00065
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Report Date
- June 21, 2013
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DTB
- PMA / PMN Number
- K896443
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE LEAD WAS ANALYZED BY THE DISTRIBUTOR, ST. JUDE MEDICAL. ANALYSIS FOUND THE HELIX DAMAGED FROM BEING TWISTED AT THE BASE OF THE LEAD HEAD. THE INSULATION WAS BROKEN AT THE BASE OF THE HEAD SHOWING WHERE THE HELIX WAS GRIPPED BY A DEVICE AND TWISTED AWAY FROM BEING CENTERED OVER THE LEAD HEAD. THE HELIX WAS PHYSICALLY DAMAGED. THE DEVICE WAS NOT RETURNED TO GREATBATCH MEDICAL FOR ANALYSIS.
Description of Event or Problem · 1
SCREW DISLODGEMENT, MECHANICAL PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335442 | 54 CM UNIPOLAR LEAD | UNIPOLAR LEAD | DTB | GREATBATCH MEDICAL | 1043K | M26410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |