BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY ADX SR

    MDR report key: 1223811 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03475
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 18, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 WHEN THE PULSE GENERATOR WAS CONNECTED TO THE LEAD, IMPEDANCE WAS GREATER THAN 2400 OHMS. INTERROGATION SHOWED THE DEVICE WAS IN BACKUP MODE. THE PULSE GENERATOR WAS REPLACED AND WITH THE NEW PULSE GENERATOR THE IMPEDANCE WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITY ADX SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5156 NA

    Patients

    Seq Age Sex Outcome Treatment
    1