FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 101
MDR report key: 831124
·
Received March 20, 2007
Report
- Report Number
- 1644487-2007-00067
- Event Type
- Other
- Date Received
- March 20, 2007
- Date of Event
- January 20, 2007
- Report Date
- January 22, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- p970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REPORTER STATED THE NCP SYSTEM WAS UNRELATED TO THE DEATH EVENT.
Description of Event or Problem · 1
REPORTER STATED PATIENT WAS FOUND DEAD IN THEIR BED BY CAREGIVER. CAUSE OF DEATH IS UNKNOWN; AN AUTOPSY IS PENDING. MANUFACTURER HAS DETERMINED THAT SUDEP IS PROBABLE. PRODUCT ANALYSIS OF THE RETURNED GENERATOR AND LEAD FOUND NO ANOMALIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE DEATH EVENT. 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 | 29479C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other |