FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1242943
·
Received November 21, 2008
Report
- Report Number
- 1644487-2008-02801
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 24, 2008
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MFR THAT THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN DEPRESSION. IT WAS ALSO INDICATED THAT THE PATIENT WAS HOSPITALIZED. THE RELATIONSHIP BETWEEN THE WORSENING DEPRESSION AND VNS THERAPY IS UNK AT THIS TIME. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS INC | 102 | 011608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |