FDA Adverse Event
Malfunction
Summary report: N
35 CM BIPOLAR STEROID ELUTING LEAD
MDR report key: 3900415
·
Received May 6, 2014
Report
- Report Number
- 2183787-2014-00055
- Event Type
- Malfunction
- Date Received
- May 6, 2014
- Date of Event
- March 19, 2014
- Report Date
- April 25, 2014
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DTB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NA.
Description of Event or Problem · 1
THIS LEAD SHOWED A HIGH IMPEDANCE STATE OF GREATER THAN 3000 OHM DURING A REMOTE SESSION. IN THE FOLLOWING WEEKS THE IMPEDANCE SHOWED VARYING MEASUREMENTS. DURING A REPLACEMENT PROCEDURE THE LEAD WAS CUT NEAR THE ELECTRODE FOR EXAMINATION PURPOSES. THE SCREW ELECTRODE WAS KEPT IN SITU (PARTLY EXPLANTED). A NEW 1084T WAS IMPLANTED TO RESOLVE THE ISSUE. NO FURTHER CONSEQUENCES FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271969 | 35 CM BIPOLAR STEROID ELUTING LEAD | BIPOLAR STEROID ELUTING LEAD | DTB | GREATBATCH MEDICAL | 1084T-55 | W1896085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |