FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1153334
·
Received September 5, 2008
Report
- Report Number
- 1644487-2008-02110
- Event Type
- Injury
- 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.
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 EXPERIENCED AN INCREASE IN ATONIC SEIZURES. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L 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 | Life Threatening |