BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 1990783 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00238
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    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 FAR-FIELD R-WAVE (FFRW) OVERSENSING IS OCCURRING WITH NORMAL BRADY FUNCTION. FALSE MODE SWITCHES WERE ALSO OBSERVED. ATTEMPTS TO ADJUST SENSING TO AVOID FFRW WERE UNSUCCESSFUL. THE DEVICE REMAINS 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 S.A. D154AWG ASKU

    Patients

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