FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1232204
·
Received November 14, 2008
Report
- Report Number
- 1644487-2008-02740
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 17, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER THAT THE PATIENT HAS BEEN HOSPITALIZED DUE TO AN INCREASE IN SEIZURES ALONG WITH A CHANGE IN SEIZURE PATTERN. IT WAS INDICATED BY THE REPORTER THAT THE PATIENT'S GENERATOR WAS NEARING END OF SERVICE PER THE NEUROLOGIST. IT WAS ALSO INDICATED BY THE REPORTER THAT THE INCREASE IS ABOVE PRE-VNS BASELINE. THE RELATIONSHIP BETWEEN THE INCREASE IN SEIZURES/CHANGE IN SEIZURE PATTERN AND VNS THERAPY IS UNKNOWN AT THIS TIME. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 4308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |