BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 100 VVI

    MDR report key: 1013446 · Received March 10, 2008

    Report

    Report Number
    6000024-2008-00011
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    October 18, 2007
    Manufacturer
    MEDTRONIC OF CANADA LTD.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 100 VVI IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC OF CANADA LTD. SVVI103 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention