BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 3920445 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14045
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, TRANSIENT PERIODS OF BRADYCARDIA AND VENTRICULAR OVERSENSING LEADING TO PACING INHIBITION WERE DISPLAYED ON THE MONITOR WHILE THE PHYSICIAN WAS USING ELECTROCAUTERY. THE PULSE GENERATOR WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396757 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR