FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 3900475
·
Received June 27, 2014
Report
- Report Number
- 1644487-2014-01618
- Event Type
- Injury
- Date Received
- June 27, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 29, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE TREATING VNS PHYSICIAN REPORTED THAT THE PATIENT'S DEVICE HAS NOT BEEN CHECKED SINCE HOSPITALIZATION. THE INCREASED SEIZURES BEGAN IN MAY 2014. PER THE PHYSICIAN'S ASSESSMENT, THE INCREASED SEIZURES WHICH WAS STILL BELOW PRE-VNS SEIZURE FREQUENCY LEVEL WERE NOT RELATED TO VNS THERAPY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL AND WAS DECLINING FAST WITH AN INCREASE IN SEIZURES. IT IS UNKNOWN IF THE SEIZURES ARE AN INCREASE ABOVE THE PATIENT'S PRE-VNS BASELINE LEVEL. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377549 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS, INC. | 103 | 201604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Hospitalization| R |