BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY DC

    MDR report key: 502949 · Received September 10, 2003

    Report

    Report Number
    2017865-2003-00429
    Event Type
    Malfunction
    Date Received
    September 10, 2003
    Date of Event
    May 23, 2003
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT INTERROGATION REVEALED >2500 OHMS VENTRICULAR LEAD IMPEDANCE AND THAT THE ATRIAL LEAD WAS UNCODED. THE IMPULSE CHARGE WAS 0UC, THE IMPULSE ENERGY WAS 0UJ AND THE CURRENT IMPULSE WAS <0.5MA. A SOFTWARE DOWNLOAD WAS NOT SUCCESSFUL. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY DC IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5230 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN