FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2052662
·
Received April 7, 2011
Report
- Report Number
- 1644487-2011-00746
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- March 10, 2011
- Report Date
- May 26, 2017
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS PT WAS HAVING INCREASED SEIZURES ABOVE PRE-VNS BASELINE LEVEL THAT WAS BELIEVED TO BE DUE TO THE VNS GENERATOR NEARING END OF SERVICE. A BATTERY ESTIMATE PERFORMED REVEALED APPROX -2.36 YEARS REMAINING. THE REPORTER HAS NOT CONFIRMED THE VNS WAS AT END OF SERVICE. MEDICATION WAS INCREASED AS AN INTERVENTION FOR THE SEIZURES, AND REPLACEMENT OF THE GENERATOR IS LIKELY. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 009273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | Required Intervention |