FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2021784
·
Received February 25, 2011
Report
- Report Number
- 1644487-2011-00324
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 28, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PATIENT WAS HAVING INCREASE IN SEIZURE DUE TO "VNS GENERATOR MALFUNCTION." MANUFACTURER REPRESENTATIVE FOLLOWED UP WITH THE PHYSICIAN AND WAS NOT ABLE TO SUCCESSFULLY INTERROGATE THE PATIENT'S DEVICE; HOWEVER, THE SAME PROGRAMMING SYSTEM WORKED WITHOUT ISSUE ON A PATIENT SEEN LATER THAT DAY AS WELL AS ON A DEMO GENERATOR. PHYSICIAN REFERRED THE PATIENT FOR SURGERY FOR PROPHYLACTIC GENERATOR REPLACEMENT. FURTHER GOOD FAITH ATTEMPTS TO OBTAIN MORE INFORMATION WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 13382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |