FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1192121
·
Received October 7, 2008
Report
- Report Number
- 1644487-2008-02430
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 9, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PT HAD MADE A SUICIDE ATTEMPT. THE PHYSICIAN'S ASSESSMENT REVEALED THAT THE MEDICAL THREAT TO LIFE WAS CHARACTERIZED AS "MODERATE" (E.G., TOOK 10 SLEEPING PILLS- BRIEFLY UNCONSCIOUS). THE PHYSICIAN INDICATED THERE WAS NO RELATIONSHIP BETWEEN THE PT'S MEDICATIONS AND THE SUICIDE GESTURE AND A PROBABLE RELATIONSHIP BETWEEN THE PT'S MENTAL DISORDER AND THE SUICIDAL GESTURE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO 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 | 015579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |