FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 2020355
·
Received March 11, 2011
Report
- Report Number
- 1644487-2011-00504
- Event Type
- Injury
- Date Received
- March 11, 2011
- Date of Event
- January 1, 2010
- Report Date
- February 9, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ARTICLE CITATION: ELLIOT, ROBERT, A. MORSI, A. SILVERBERG, C. CARLSON, E. GELLER, O. DEVINSKY AND W. DOYLE. "VAGUS NERVE STIMULATION IN 436 CONSECUTIVE PATIENTS WITH TREATMENT-RESISTANT EPILEPSY: LONG-TERM OUTCOMES AND PREDICTORS OF RESPONSE.
Description of Event or Problem · 1
IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A VNS PT EXPERIENCED COMPLICATIONS INCLUDING SUPERFICIAL INFECTION WHICH WAS MINOR AND TREATED WITH ANTIBIOTICS. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | NONE | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |