FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1222383
·
Received November 5, 2008
Report
- Report Number
- 1644487-2008-02673
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- April 21, 2008
- Report Date
- October 6, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE TREATING NEUROLOGIST INDICATED IN 2008 THAT THE PT'S SEIZURES WERE BELOW PREVNS BASELINE LEVELS STILL. ADDITIONAL INFO FROM THE SURGEON ABOUT 4 MONTHS LATER INDICATED THAT THE PT'S SEIZURES ARE ABOVE PRE-VNS BASELINE. DIAGNOSTICS SHOW VNS TO BE FUNCTIONING PROPERLY, AND NOT AT END OF SERVICE. THE PT UNDERWENT GENERATOR REVISION SURGERY. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MFR, AND IS UNDERGOING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |