FDA Adverse Event
Injury
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1021317
·
Received March 27, 2008
Report
- Report Number
- 1644487-2008-00818
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- January 1, 2008
- Report Date
- February 27, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT PT WAS UNDERGOING EXPLORATORY SURGERY, BECAUSE PT WAS HAVING "PROBLEMS" WITH VNS THERAPY. DURING THE PROCEDURE THE LEAD WAS ACCIDENTALLY CUT BY THE SURGEON. ADDITIONALLY, ONE OF THE ELECTRODES WAS FOUND TO BE OFF OF THE NERVE. DURING THE SAME PROCEDURE, THE PT'S LEAD AND GENERATOR WERE REPLACED, AND THE EXPLANTED PRODUCTS WERE RETURNED TO MFR FOR ANALYSIS. TO DATE THAT ANALYSIS IS NOT YET COMPLETE. GOOD FAITH ATTEMPTS FOR FURTHER INFO ARE CURRENTLY BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |