FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1192119
·
Received October 7, 2008
Report
- Report Number
- 1644487-2008-02435
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- May 28, 2008
- Report Date
- September 23, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD HEADACHES AND TIREDNESS RELATED TO THE VNS STIMULATION AND THAT SHE WANTS TO HAVE IT EXPLANTED. WHEN THE PT IS AT LOWER SETTINGS SHE DOES NOT HAVE THE EVENT OR WHEN THE MAGNET IS USED TO DISABLE THE VNS THERAPY. AT LOWER SETTINGS, SHE DOES NOT HAVE GOOD SEIZURE CONTROL BUT AT HIGHER SETTINGS, SHE HAS THE HEADACHES AND TIREDNESS. THE PT'S PHYSICIAN REPORTED THAT THE HEADACHES WERE IMPAIRING FOR THE PT. NO SURGERY DATE SET AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 017152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female | Other |