FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2172671
·
Received July 20, 2011
Report
- Report Number
- 1644487-2011-01626
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- February 1, 2011
- Report Date
- June 23, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NURSE THAT A VNS PT WAS NOT ABLE TO TOLERATE VNS STIMULATION AND HER DEVICE WAS TURNED OFF IN (B)(6) 2011. THERE HAS NOT BEEN ANY SEIZURE CHANGE SINCE DISABLEMENT OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 009771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |