FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1172588
·
Received September 19, 2008
Report
- Report Number
- 1644487-2008-02287
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 22, 2008
- Report Date
- August 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS THERAPY PATIENT IS REPORTING DAYTIME SLEEPINESS AND INCREASED NIGHTTIME SEIZURES. A BATTERY LIFE CALCULATION REVEALED THE GENERATOR IS 0.08 YEARS UNTIL THE ELECTIVE REPLACEMENT INDICATOR READS "YES". GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 011989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |