FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2220283
·
Received August 16, 2011
Report
- Report Number
- 1644487-2011-01876
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- March 1, 2011
- Report Date
- July 18, 2011
- 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 NEUROSURGEON THAT A VNS PT STARTED HAVING INCREASED SEIZURES STARTING IN (B)(6) 2011. THE PT SEIZURES GRADUALLY INCREASED TO WHERE SHE HAD MORE THAN 20 SEIZURES PER DAY. THE PHYSICIAN DESCRIBED THE PT SEIZURE CHARACTERISTICS SIMILAR TO HER PRIOR SEIZURES. THE VNS DEVICE WAS FOUND TO BE AT THE END OF SERVICE SUGGESTING BATTERY WAS NEARING END OF LIFE. THE PHYSICIAN DID NOT KNOW IF PT'S INCREASE IN SEIZURES WAS RELATED TO VNS DEVICE BEING AT END OF SERVICE OR DUE TO POST OPERATIVE INTERVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 012991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |