BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 1792297 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03204
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE PATIENT REPORTED HAVING: "A LOT" OF "LIKE AN ELECTRIC SHOCK", "SMALL SHOCKS" IN HIS CHEST AREA INTERMITTENTLY FOR ABOUT ONE MONTH AND WAS WONDERING IF THEY WERE RELATED TO THE DEVICE. THE PATIENT WAS DIRECTED TO THEIR PHYSICIAN. THERE ARE NO FURTHER COMPLAINTS OR INQUIRIES NOTED FROM THE DEVICE OR THE PATIENT. THE DEVICE REMAINS IMPLANTED AND IN USE.

    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 71 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| 6943 IMPLANTABLE TACHY LEAD