FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1001422
·
Received January 25, 2008
Report
- Report Number
- 1001422
- Event Type
- Malfunction
- Date Received
- January 25, 2008
- Date of Event
- November 30, 2007
- Report Date
- January 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OK, US
Narratives
Description of Event or Problem · 1
VAGAL NERVE STIMULATOR HAD TO BE EXPLANTED DUE TO FAILURE AFTER A BASEBALL HIT PATIENT AT IMPLANT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | STIMULATOR, VAGAL NERVE | LYJ | CYBERONICS, INC. | 102 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | NO OTHER THERAPIES| NO OTHER THERAPIES |