FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 302
MDR report key: 1020274
·
Received March 25, 2008
Report
- Report Number
- 1644487-2008-00781
- Event Type
- Injury
- Date Received
- March 25, 2008
- Date of Event
- October 17, 2007
- Report Date
- February 27, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT ONE OF THE PT'S VOCAL CORDS WAS PARALYZED. NO FURTHER INFO HAS BEEN ATTAINED AFTER GOOD FAITH ATTEMPTS TO GATHER ADD'L INFO HAVE BEEN MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 200614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |