FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1230457
·
Received November 7, 2008
Report
- Report Number
- 1644487-2008-02706
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 8, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED HE TRIED TWICE TO INTERROGATE A VNS THERAPY PATIENT'S GENERATOR, BUT HE WAS UNABLE TO ESTABLISH COMMUNICATION. THE PHYSICIAN BELIEVES THE NON-COMMUNICATION EVENT IS DUE TO NORMAL END OF SERVICE. A BATTERY LIFE CALCULATION REVEALED THE GENERATOR IS 1.62 YEARS REMAINING UNTIL ERI = 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 | 015950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |