BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER VIEW EXTRA DISTAL SUPPORT J GUIDE WIRE

    MDR report key: 1041396 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32148
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 4, 2008
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER VIEW EXTRA DISTAL SUPPORT J GUIDE WIRE GUIDE WIRE DTB CARDIAC PACEMAKERS 4639 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 4639 WAS USED DURING THE EVENT.| THE DEVICE H120/106505 WAS IMPLANTED