FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2190777
·
Received July 26, 2011
Report
- Report Number
- 1644487-2011-01682
- Event Type
- Injury
- Date Received
- July 26, 2011
- Date of Event
- May 25, 2011
- Report Date
- July 7, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA CLINIC NOTES THAT VNS PT'S GENERATOR SETTINGS WERE REDUCED TO CONSERVE BATTERY LIFE; HOWEVER, PT STARTED HAVING MORE SEIZURES. THE NEUROLOGIST INCREASED PT'S SETTINGS BUT PT WAS NOT ABLE TO TOLERATE THE SETTINGS. SO THE PHYSICIAN REDUCED THE OUTPUT CURRENT TO 2MA BUT INCREASED THE FREQUENCY TO 30HZ. BOTH NORMAL AND SYSTEM MODE DIAGNOSTICS WERE WITHIN NORMAL LIMIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 201195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |