FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1000468
·
Received February 21, 2008
Report
- Report Number
- 1644487-2008-00366
- Event Type
- Injury
- Date Received
- February 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- January 23, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS PT HAD AN INCREASE IN SEIZURES ABOVE PRE-VNS BASELINE LEVELS. THE REPORTER HAS STATED THE PT'S SEIZURES HAVE BECOME WORSE SINCE HORMONAL THERAPY WAS INITIATED. THE PT DOES FEELS REGULAR VNS STIMULATION. THE RELATIONSHIP BETWEEN THE INCREASED SEIZURES AND THE VNS IS UNK PER THE REPORTER. FURTHER ATTEMPTS FOR INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 016158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |