BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO VR

    MDR report key: 2061624 · Received April 18, 2011

    Report

    Report Number
    2647346-2011-00562
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 22, 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
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE PATIENT HAD SINUS VENTRICULAR TACHYCARDIA (SVT) EPISODES. THESE EPISODES WERE NOT SEEN VIA THE "QUICK LOOK REPORT" BUT UNDER "EPISODES" THROUGH THE CARELINK TRANSMISSION. THE CLINICIAN MISSED THE TACHYCARDIA DUE TO THIS AND REQUESTED THAT ALL SVT EPISODES BE RECORDED ON THE "QUICK LOOK" PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other 0180 IMPLANTABLE TACHY LEAD