FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1012691
·
Received March 11, 2008
Report
- Report Number
- 1644487-2008-00678
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- November 4, 2007
- Report Date
- February 13, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS STUDY PATIENT WAS HOSPITALIZED FOR A SUICIDE ATTEMPT. THE REPORTER HAS STATED THE SUICIDE ATTEMPT IS UNRELATED TO VNS IMPLANTATION SURGERY AND UNLIKELY RELATED TO VNS STIMULATION. PER THE REPORTER, THE PATIENT IS CURRENTLY DOING WELL IN THE COMMUNITY AND IS RECEIVING AND SENSING HER REGULAR VNS STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 | 016740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |