FDA Adverse Event
Injury
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 2001039
·
Received February 21, 2011
Report
- Report Number
- 1644487-2011-00317
- Event Type
- Injury
- Date Received
- February 21, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 1, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD EXPERIENCED VOCAL CORD PARALYSIS. NO FURTHER INFO WAS GIVEN. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNKNOWN | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |