BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2291016 · Received October 13, 2011

    Report

    Report Number
    2182208-2011-02211
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KFJ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS ATTEMPTING TO PLACE THE LEAD INTO THE COMPETITOR DEVICE FIVE WRENCHES BROKE WHILE TIGHTENING AND UNTIGHTENING THE SETSCREW. IT WAS NOTED THAT THE METAL CAME OUT OF THE WRENCHES. IT WAS ALSO REPORTED THAT THE LEAD HAD INCREASING IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LEAD SERVICE KIT KFJ MEDTRONIC, INC. 5873W ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 6949 IMPLANTABLE TACHY LEAD| T180 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB