BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 1991299 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00865
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INTERROGATING THE DEVICE, THE PACING PERCENTAGES ALL DISPLAY "???" IN THE FIELD, AND THE OBSERVATION SCREEN STATES THAT THE CARDIAC COMPASS DATA AND RATE HISTOGRAM DATA IS INVALID. THE PATIENT STATED THAT THEY HAD BEEN UNDERGOING RADIATION THERAPY. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD