BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO II VR

    MDR report key: 2051327 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01526
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    December 25, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S157
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    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 HAS FELT SICK, WEAK, AND DIZZY SINCE RECEIVING A THERAPY FROM THE DEVICE. THE PATIENT STATED IT FELT DIFFERENT THAN THE PRIOR DEVICE. THE DEVICE REMAINS IN USE PER THE MANUFACTURERS IMPLANT RECORD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D274VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 6944 IMPLANTABLE TACHY LEAD