FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1153203
·
Received September 5, 2008
Report
- Report Number
- 1644487-2008-02106
- Event Type
- Death
- Date Received
- September 5, 2008
- Date of Event
- January 1, 1999
- Report Date
- August 11, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BEN-MENACHEM E, HELLSTROM K, WALDTON C, AUGUSTINSSON LE. EVALUATION OF REFRACTORY EPILEPSY TREATED WITH VAGUS NERVE STIMULATION FOR UP TO 5 YEARS. NEUROLOGY 1999;52(APRIL):1265-7. SEE SCANNED PAGES.
Description of Event or Problem · 1
IT WAS REPORTED IN AN ARTICLE DETAILING A 5-YEAR FOLLOW UP STUDY ON PT'S IMPLANTED WITH THE VNS DEVICE THAT A PT DIED DUE TO STATUS EPILEPTICUS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO SURROUNDING THE PT AND THE EVENT 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 | Death |