FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1222387
·
Received November 5, 2008
Report
- Report Number
- 1644487-2008-02670
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 8, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTED SUICIDAL GESTURES ON EITHER SLICE C OR SUICIDE ASSESSMENT FORMS, REGISTRY PATIENT. PATIENT HAS TWO GESTURES, SUICIDE ATTEMPTS. MILD IN NATURE, IE TOOK PILLS. NO SPECIFIC INFO PROVIDED AS TO WHAT PT DID. NO REPORT OF WHAT INTERVENTIONS WERE TAKEN IF ANY. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFO, BUT THUS FAR NO FURTHER INFO HAS BEEN REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 | 015094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |