FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL
MDR report key: 1080755
·
Received July 23, 2008
Report
- Report Number
- 1644487-2008-01686
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THE PT HAS HAD AN INCREASE IN SEIZURES IN THE LAST WEEK AND A HALF AND THE PATIENT'S MOTHER IS VERY CONCERNED. THE PATIENT'S MOTHER HAS BEEN SWIPING THE MAGNET EXTRA AND SAYS THE PT LOOKS UNCOMFORTABLE WITH THE EXTRA MAGNET STIMULATION. THE PT REPORTS HER CHEEKS HURT. DEVICE DIAGNOSTICS WITHIN NORMAL LIMITS. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL DETAILS SURROUNDING EVENTS. IT IS UNKNOWN IF THE SEIZURES REPORTED ARE ABOVE OR BELOW THE PATIENT'S PRE VNS SEIZURE RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |