FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1081553
·
Received July 25, 2008
Report
- Report Number
- 1644487-2008-01696
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- January 1, 2008
- Report Date
- June 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT'S MOTHER REPORTED THAT THE PT HAS HAD AN INCREASE IN SEIZURES ABOVE PRE-VNS BASELINE SINCE IMPLANTED WITH VNS. ADDITIONALLY, IT WAS REPORTED THAT THE PT WOULD LIKE TO HAVE THE DEVICE EXPLANTED BECAUSE HE NEEDS ROUTINE FULL BODY MRIS. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |