BEUDAMED
    FDA Adverse Event Other Summary report: N

    VNS THERAPY PULSE MODEL 102 GENERATOR

    MDR report key: 689240 · Received March 17, 2006

    Report

    Report Number
    1644487-2006-00142
    Event Type
    Other
    Date Received
    March 17, 2006
    Date of Event
    February 13, 2006
    Report Date
    February 16, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT PASSED AWAY OF APPARENT SUICIDE. IT WAS REPORTED THAT WHEN THE PT'S BODY WAS FOUND, IT APPEARED THAT HE HAD BEEN EXPIRED FOR A FEW DAYS. TREATING PHYSICIAN SUSPECTS THAT SUICIDE WAS THE CAUSE OF DEATH, BASED ON THE PT'S HITORY, AND DOES NOT FEEL THAT IT WAS VNS-RELATED. CLINIC NOTES FROM OFFICE VISIT APPROX FIVE MONTHS PRIOR TO DEATH INDICATE THAT THE PT HAD CONCERNS REGARDING RECURRENCE OF SUICIDAL IDEATION. AUTOPSY WAS NOT PERFORMED AND THE DEVICE WAS BURIED WITH THE PT. THERE IS NO EVIDENCE AT THIS TIME THAT THE VNS THERAPY SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE MODEL 102 GENERATOR MUZ MUZ CYBERONICS, INC. 102 13177

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other