FDA Adverse Event
Summary report: N
CYBERONICS MODEL 104
MDR report key: 7365760
·
Received March 22, 2018
Report
- Report Number
- MW5076033
- Date Received
- March 22, 2018
- Date of Event
- June 14, 2016
- Report Date
- March 20, 2018
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IN MARCH, I WENT TO SEE MY NEUROLOGIST TO CHECK ON VNS MODEL 104 AND BASIC CHECKUP EVALUATION. MY NEUROLOGIST SAID THE BATTERY IS DEAD ON WHEN TRYING TO READ THE VNS MODEL. ON PRIOR VISITS WITH MY NEUROLOGIST SHE COULD READ AND EVALUATE THE DEVICE. SINCE THE DEVICE WAS INSTALLED 1 AND A HALF YEARS AGO THE BATTERY LIFE HAS BEEN INACCURATE. THE BATTERY LIFE IS 3 TO 8 YEARS LIFESPAN. I HAVE SEEN SAME RECALL ON SAME DEVICE ON FDA WEBSITE ON PAGE 41 OF 156 FROM 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204111 | CYBERONICS MODEL 104 | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY | LYJ | LIVANOVA USA, INC. | CYBERONICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |