FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 101
MDR report key: 785944
·
Received November 21, 2006
Report
- Report Number
- 1644487-2006-00427
- Event Type
- Other
- Date Received
- November 21, 2006
- Date of Event
- October 26, 2006
- Report Date
- October 30, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REPORTER STATED NCP SYSTEM UNRELATED TO DEATH EVENT.
Description of Event or Problem · 1
REPORTER STATED THAT PATIENT WAS FOUND DEAD IN THEIR BED BY CAREGIVER. CAUSE OF DEATH IS UNKNOWN AND NO AUTOPSY WILL BE DONE. MANUFACTURER HAS DETERMINED THAT SUDEP IS PROBABLE. THE REPORTER HAS STATED THE NCP SYSTEM WAS UNRELATED TO THE DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | LYJ | CYBERONICS, INC. | 101 | 7630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Other |