FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 2933763
·
Received January 29, 2013
Report
- Report Number
- 1644487-2013-00233
- Event Type
- Injury
- Date Received
- January 29, 2013
- Date of Event
- June 6, 2012
- Report Date
- January 8, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT'S HEALTH PROFILE DATED (B)(6) 2012 INDICATED THE PATIENT HAS A DIAGNOSIS OF SELF INJURIOUS BEHAVIOR. IT IS NOT CLEAR IF THE PATIENT WAS DIAGNOSED PRE OR POST-VNS IMPLANT. THE RELATIONSHIP TO VNS THERAPY IS UNCLEAR AT THIS TIME. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE TREATING VNS PHYSICIAN'S OFFICE HAVE BEEN UNSUCCESSFUL TO DATE. OF NOTE, IT WAS MENTIONED IN THE NOTES THAT THE PATIENT HAS A MEDICAL HISTORY OF DEPRESSION RELATED TO SEIZURE DISORDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39813 | PULSE GEN MODEL 102R | GENERATOR | LYJ | CYBERONICS INC | 102R | 200843 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |