FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 2181398
·
Received July 21, 2011
Report
- Report Number
- 1644487-2011-01653
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- December 1, 2010
- Report Date
- June 21, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA CLINIC NOTES RECEIVED THAT THE VNS PATIENT WAS EXPERIENCING RECURRENT SEIZURES HOWEVER THE CAUSE OF THESE SEIZURES WAS UNKNOWN. THE RELATION OF THESE INCREASED SEIZURES TO PRE-VNS FREQUENCIES IS UNKNOWN. ALTHOUGH THE PATIENT'S DILANTIN WAS NOTED TO BE SUBTHERAPEUTIC, THIS IS NOT BELIEVED TO BE A FACTOR AS PER THE SITE. NO TRAUMA OR MANIPULATION IS BELIEVED TO HAVE OCCURRED AND NO OTHER EXTERNAL CONTRIBUTING FACTORS HAVE BEEN REPORTED. SURGERY TO REPLACE THE PATIENT'S GENERATOR IS LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R | 010789 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |