BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO VR

    MDR report key: 1691882 · Received May 18, 2010

    Report

    Report Number
    6000144-2010-02039
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    March 7, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 BY THE PATIENT'S MOTHER THAT "MACHINE DID NOT WORK", "HIS HEART STOPPED", AND "DEFIB DID NOT KICK IN AND HE DIED." THE PATIENT'S MOTHER REPORTED SHE UNDERSTOOD THE CAUSE OF DEATH TO BE "SUDDEN CARDIAC ARREST." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    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 49 YR Death 6947 IMPLANTABLE TACHY LEAD