FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 6167994
·
Received December 12, 2016
Report
- Report Number
- 1644487-2016-02843
- Event Type
- Malfunction
- Date Received
- December 12, 2016
- Date of Event
- November 1, 2016
- Report Date
- January 19, 2017
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT WAS SEEN IN CLINIC AFTER THE INCREASED SEIZURES WERE REPORTED TOT MANUFACTURER AND THE DEVICE WAS CHECKED. DIAGNOSTICS TEST RESULTS WERE NOT DOCUMENTED. DURING THAT VISIT, NO SEIZURES WERE REPORTED BY THE PATIENT. THERE WAS NO SIGNIFICANT INCREASE IN SEIZURES THAT WERE NOTED OR REPORTED BY PATIENT AT THAT TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES THAT IS BELIEVED TO BE DUE TO BATTERY DEPLETION. AN AUTOMATIC BATTERY LIFE CALCULATION WAS PERFORMED WITH THE AVAILABLE INFORMATION, WHICH SHOWS THAT THE DEVICE HAS > 10 YEARS TO NEOS - YES. NO ADDITIONAL RELEVANT INFORMATION WAS RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 819057 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS, INC. | 103 | 3377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |