FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 100C
MDR report key: 2230510
·
Received August 12, 2011
Report
- Report Number
- 1644487-2011-01860
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- January 1, 2000
- Report Date
- July 14, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS NOTED AS HAVING AN INCREASE IN THE DURATION OF SEIZURES AND ICTAL SEVERITY OF SEIZURES AT THE 1-YEAR FOLLOW-UP. IT WAS ALSO INDICATED THAT THE PT'S STATUS EPILEPTICUS WAS SHOWING AN INCREASE IN FREQUENCY. A SEARCH PERFORMED IN THE MFR'S PROGRAMMING HISTORY DATABASE DID NOT PROVIDE ANY INFO ON PT DEVICE DIAGNOSTICS. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 100C | LYJ | CYBERONICS, INC. | 100C | 21867C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |