BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 6159897 · Received December 9, 2016

    Report

    Report Number
    2017865-2016-07641
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 9, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THE WRENCHES COULD NOT ENGAGE THE ATRIAL SETSCREW TO UNTIGHTEN IT DUE TO CALCIFIED BLOOD FILLING THE SETSCREW INSET. THE CALCIFIED BLOOD WAS PREVENTING AND LIMITING WRENCH INSERTION INTO THE SETSCREW INSET SUCH THAT THE INSET COULD NOT BE ENGAGED BY THE WRENCH. THE WRENCH COULD NOT PENETRATE THROUGH THE HARDENED CALCIFIED BLOOD AND THE SETSCREW COULD NOT BE UNTIGHTENED TO REMOVE THE LEAD DUE TO THIS CONDITION. THE BLOOD MOST LIKELY CAME THROUGH DAMAGE TO THE SEPTUM IN THE FORM OF A PUNCHED HOLE. THE DEVICE HAD NORMAL BATTERY DEPLETION AND BACKUP VVI OCCURRED POST EXPLANT DUE TO AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    DURING DEVICE EXCHANGE, THE NON-SJM ATRIAL LEAD COULD NOT BE REMOVED FROM THE HEADER OF THE DEVICE. THE LEAD AND THE DEVICE WERE EXPLANTED AND REPLACED AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814906 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC. 5386 3010326

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BIOTRONIK Y60 ATRIAL LEAD