BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOLETRA

    MDR report key: 640504 · Received October 11, 2005

    Report

    Report Number
    6000032-2005-01582
    Event Type
    Other
    Date Received
    October 11, 2005
    Date of Event
    September 27, 2005
    Report Date
    October 5, 2005
    Manufacturer
    MEL REL, INCORPORATED
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    LAWSUIT ALLEGES IN 2004, AT A ROUTING ADJUSTMENT OF THE DEVICE BY HCP, THE PATIENT WAS SUBJECT TO ELECTROCUTION. LAWSUIT ALLEGES "DEVICE WAS UNSAFE BECAUSE IT DID NOT HAVE A SAFETY MECHANSIM INHIBITING MAXIMUM SHOCK, AND THUS, ALLOWED FOR ENOUGH SHOCK TO ACTUALLY ELECTROCUTE" THE PATIENT. NO REPORT OF DEVICE EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA INS MHY MEL REL, INCORPORATED 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O