FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR LEAD MODEL 300
MDR report key: 1910052
·
Received November 10, 2010
Report
- Report Number
- 1644487-2010-02529
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 11, 2010
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT SHOWED HIGH LEAD IMPEDANCE ON SYSTEM MODE DIAGNOSTICS. PT'S DEVICE WAS TURNED OFF AS A RESULT. CHEST X-RAYS WERE TAKEN BUT WERE NOT AVAILABLE FOR MANUFACTURER FOR FURTHER REVIEW. PHYSICIAN WANTS TO MONITOR THE PT AT THE MOMENT BEFORE REPLACEMENT. LAST GOOD DIAGNOSTICS WERE OBTAINED IN (B)(6) 2010 AS PER PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR LEAD MODEL 300 | LYJ | CYBERONICS INC | 300-20 | 4185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |