FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 302
MDR report key: 1120738
·
Received August 15, 2008
Report
- Report Number
- 1644487-2008-01917
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 18, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT'S LEAD IS PROTRUDING. SURGERY IS LIKELY TO REIMPLANT THE LEAD DEEPER. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |