FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 4192828
·
Received October 22, 2014
Report
- Report Number
- 1644487-2014-02780
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 29, 2014
- Report Date
- September 29, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS ATTAINED THAT THE PATIENT WAS SEEN BY THEIR TREATING PHYSICIAN OVER (B)(6) 2014 AND THEY WERE DOING VERY WELL. THEY WERE NOT AWARE OF ANY INCREASED SEIZURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670816 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS INC | 103 | 202462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |