BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY ADX SR

    MDR report key: 1073325 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02119
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 9, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    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. FINAL ANALYSIS FOUND NO VENTRICULAR OUTPUT. THE CERAMIC BOARD INTERFACING THE HYBRID TO THE FEEDTHRU WAS FRACTURED, CREATING AN OPEN CIRCUIT BETWEEN CONNECTOR FEEDTHRU AND","HYBRID OUTPUT. NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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