FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1052621
·
Received May 28, 2008
Report
- Report Number
- 1644487-2008-01197
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT PT IS EXPERIENCING AN INCREASE IN SEIZURES. PT'S PRE-VNS BASELINE SEIZURE RATE IS UNK TO MFR AT THIS TIME. DIAGNOSTIC TESTING ON THE PT'S DEVICE YIELDED RESULTS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION. IT WAS REPORTED THAT PT WILL BE SCHEDULED FOR A GENERATOR REPLACEMENT PROCEDURE. GOOD FAITH ATTEMPTS FOR FURTHER INFO ARE CURRENTLY BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 009771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |