FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1940565
·
Received December 21, 2010
Report
- Report Number
- 1644487-2010-02867
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- November 23, 2010
- Report Date
- November 23, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A VNS PATIENT HAD BEEN ADMITTED TO THE ER AS THE PATIENT WAS EXPERIENCING STATUS EPILEPTICUS. PER THE ADMITTING HOSPITAL, THE PATIENT'S VNS BATTERY WAS AT END OF SERVICE AND THEY WERE NOT NECESSARILY ATTRIBUTING THE SEIZURE ACTIVITY TO THE END OF SERVICE. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY DUE TO END OF SERVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE TREATING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 200784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |