FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 1153332
·
Received September 5, 2008
Report
- Report Number
- 1644487-2008-02140
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- August 12, 2008
- Report Date
- August 13, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER INDICATED THAT A VNS PT HAD EXPERIENCED A CHANGE IN SEIZURE PATTERN AS HIS SEIZURES, WHICH GENERALLY OCCURRED WHILE ENTERING SLEEP, WERE BEGINNING TO OCCUR EARLIER IN THE EVENING. ADDITIONALLY, IT WAS REPORTED THAT THE VNS PT'S GENERATOR COULD NOT BE INTERROGATED AND THAT THE DEVICE WAS SUSPECTED TO HAVE REACHED NORMAL END OF SERVICE. A BATTERY LIFE CALCULATION WAS PERFORMED INDICATING -0.98 YEARS TO ERI=YES. THE RELATIONSHIP BETWEEN THE CHANGE IN SEIZURE PATTERN AND THE DEVICE IS UNK AT THIS TIME. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R | 011537 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |