BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY AFX

    MDR report key: 382717 · Received March 8, 2002

    Report

    Report Number
    2017865-2002-00213
    Event Type
    Malfunction
    Date Received
    March 8, 2002
    Date of Event
    December 1, 2001
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE DEVICE NOTES THAT THE PATIENT UNDERWENT EXTERNAL DEFIBRILLATIONS. THE DEVICE WENT TO VVI MODE. PROGRAMMING TO OVO CAUSED SPIKES IN THE ECG. THE PATIENT'S CONDITION WAS "WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY AFX IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5346 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN