FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 1993856
·
Received February 11, 2011
Report
- Report Number
- 1644487-2011-00241
- Event Type
- Injury
- Date Received
- February 11, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 14, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NURSE THAT A VNS PT HAD AN INCREASE IN SEIZURES ABOVE PRE-VNS BASELINE. THE TREATING NURSE BELIEVES THAT THE INCREASE IN SEIZURES IS DUE TO LOSS OF THERAPY. THERE HAS BEEN MANY MEDICATION AND PROGRAMMING CHANGES FOR PT'S SEIZURE CONTROL. ADDITIONALLY, PT COMPLAINED ABOUT PAINFUL STIMULATION WHICH DID NOT RESOLVE WITH SETTINGS ADJUSTMENT. PLACING A MAGNET OVER THE GENERATOR TO DISABLE THE DEVICE; HOWEVER, ALLEVIATED THE PAIN IN NECK. THERE HAS BEEN NO TRAUMA OR MANIPULATION TO THE VNS GENERATOR AND LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 2586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention |