FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1662673
·
Received April 16, 2010
Report
- Report Number
- 1644487-2010-00930
- Event Type
- Death
- Date Received
- April 16, 2010
- Date of Event
- September 3, 2004
- Report Date
- March 17, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD DIED SEVERAL YEARS AGO. THE NURSE STATED THAT THE DEATH WAS NOT RELATED TO SEIZURES AND THE PATIENT WAS VERY ILL AND DIED IN THE INTENSIVE CARE UNIT. REPORTER COULD NOT REMEMBER ANY OTHER DETAILS. THE RELATIONSHIP TO VNS IS CURRENTLY UNKNOWN. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
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 | 50 YR | Death |