FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1587586
·
Received January 19, 2010
Report
- Report Number
- 1644487-2010-00133
- Event Type
- Malfunction
- Date Received
- January 19, 2010
- Date of Event
- January 16, 2003
- Report Date
- December 21, 2009
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ARTICLE CITATION: MURPHY, JEROME V., RICHARD TORKELSON, IRENE DOWLER, AND STEPHEN SIMON. "VAGAL NERVE STIMULATION IN REFRACTORY EPILEPSY." ARCH PEDIATR ADOLESC MED 157 (2003): 560-64. PRINT.
Description of Event or Problem · 1
IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A VNS PT EXPERIENCED AN INCREASE IN SEIZURES DUE TO UNK REASON AS THE CAUSE OF EPILEPSY AND SEIZURE TYPE WAS VARIABLE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |