FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1212783
·
Received October 27, 2008
Report
- Report Number
- 1644487-2008-02598
- Event Type
- Injury
- Date Received
- October 27, 2008
- Date of Event
- September 28, 2008
- Report Date
- September 28, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES AND THEY WOULD LIKE TO REPLACE THE PATIENT'S GENERATOR AS SOON AS POSSIBLE. IT IS NOT KNOWN IF THE PATIENT'S INCREASE IN SEIZURES ARE ABOVE THEIR PRE VNS RATE. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL DETAILS AND SO FAR NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 4398 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |