FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2220295
·
Received August 16, 2011
Report
- Report Number
- 1644487-2011-01881
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- June 1, 2011
- Report Date
- July 18, 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 THAT A VNS PT HAD AN INCREASE IN SEIZURES WITH FOUR DROP ATTACKS IN ONE DAY. THE PT ALSO HAD 17 DROP ATTACKS AND 34 SMALL SEIZURES ON JUNE 13TH. IT IS UNCLEAR WHEN THE FOUR DROP ATTACK SEIZURES OCCURRED. THE CLINIC NOTES RECEIVED THAT REPORTED THIS INFO INDICATED THE PT WOULD BE REFERRED FOR REVISION SURGERY DUE TO SUSPECTED END OF SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 200900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |