BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 2014079 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01762
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 6, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS INTERROGATED SEVERAL TIMES BUT THERE WAS NO SENSING EVEN WHEN THE SETTINGS WERE CHANGED. R-WAVE TESTING REVEALED 2.2 MV INITIALLY THEN 0.2 MV. THE VENTRICULAR SENSITIVITY WAS 2.0 MV. R-WAVE AMPLITUDE WAS THEN TESTED MANUALLY AND THE RESULT WAS GREATER THAN 12.5 MV. AFTER PERFORMING THE AUTO- CAPTURE SETUP TEST, SIGNALS APPEARED ON THE EGM CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1