FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1193206
·
Received October 7, 2008
Report
- Report Number
- 1644487-2008-02431
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- December 1, 2007
- Report Date
- September 9, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT THE VNS PT WAS EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY SINCE 2007, RELATIONSHIP TO PRE-VNS BASELINE UNK. ADDITIONALLY, THE PT REPORTED MUSCLE SPASMS IN THE NECK DURING STIMULATION ON-TIMES. THE PT HAS NOT BEEN TO A PHYSICIAN TO HAVE THE VNS DEVICE CHECKED, SINCE THE ONSET OF THE REPORTED EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFO ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 015790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |