BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY DR

    MDR report key: 1073320 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02114
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 1, 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 Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER A SYNCOPAL EPISODE. THIS WAS THE THIRD TIME THE PATIENT HAD BEEN ADMITTED DUE TO SYNCOPY. SHORTLY AFTER THE PATIENT WAS MOVED TO THE ICU, THE ELECTROGRAM SHOWED 3 PACED BEATS HAD FAILED TO CAPTURE AND NO BACKUP PULSES WERE DELIVERED DESPITE AUTOCAPTURE BEING ENABLED. THIS WAS RESOLVED BY TURNING AUTOCAPTURE OFF, AND THE OUTPUT PROGRAMMED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5330 NA

    Patients

    Seq Age Sex Outcome Treatment
    1