FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 1213760
·
Received October 22, 2008
Report
- Report Number
- 1644487-2008-02548
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 23, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT BEGAN EXPERIENCING SEIZURES AT NIGHT. INFO RECEIVED INDICATES THAT THE PT'S OVERALL SEIZURE COUNT HAS NOT INCREASED, HOWEVER; HE TYPICALLY DOES NOT HAVE SEIZURES AT NIGHT. NO ADD'L INFO IS AVAILABLE AS THE PT'S TREATING PHYSICIAN HAS NOT EXAMINED HIM TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 200774 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |