BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 1896980 · Received November 11, 2010

    Report

    Report Number
    2017865-2010-05306
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    August 10, 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 Location
    MA
    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 PATIENT PRESENTED ASYMPTOMATIC AND IN ATRIAL FIBRILLATION. THE PULSE GENERATOR WAS IN VVIR, 60 PPM, 2.0 MV SENSING UNIPOLAR-TIP. THERE WERE 27 HIGH VENTRICULAR RATE (HVR) EPISODES RECORDED. ONE WEEK PRIOR, 4700 HVR EPISODES WERE RECORDED. NOISE WAS NOT REPRODUCIBLE WITH POCKET STIMULATION. THE STORED EGM CONFIGURATION WAS PROGRAMMED TO UNIPOLAR-RING. THE PATIENT WILL BE MONITORED.

    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 76 YR