BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR, DF4 CONNECTOR

    MDR report key: 3220339 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04430
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    January 31, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ANALYSIS IDENTIFIED AN ERROR MESSAGE ON THE PROGRAMMER WHEN ATTEMPTING TO INTERROGATE THE DEVICE. THE DEVICE WAS TESTED USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL. AFTER THE DEVICE WAS REPROGRAMMED, THE DEVICE WAS ABLE TO INTERROGATE NORMALLY ON THE BENCH. THE CAUSE OF THE ISSUE IS BELIEVED TO BE DUE TO DATA CORRUPTION. THE ROOT CAUSE OF THE DATA CORRUPTION WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS PULLED FROM STOCK ROTATION DUE TO A NON-SPECIFIC MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320353 FORTIFY ASSURA VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1