FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1199830
·
Received October 16, 2008
Report
- Report Number
- 1644487-2008-02477
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 18, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT A PT PARTICIPATING IN A STUDY WAS SUFFERING FROM WORSENING DEPRESSION AND SUICIDAL IDEATION. IT IS NOT NOTED WHETHER THE DEPRESSION IS ABOVE OR BELOW PRE-VNS BASELINE, BUT IT WAS REPORTED AS A CONTINUOUS AND SEVERE CONDITION. THE PT WAS SUBSEQUENTLY HOSPITALIZED. PER REPORTER, THE EVENT IS POSSIBLY RELATED TO VNS THERAPY, BUT THE CORRELATION CANNOT BE CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 | 200590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization |