BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO II DR

    MDR report key: 2090427 · Received May 16, 2011

    Report

    Report Number
    2647346-2011-00691
    Event Type
    Death
    Date Received
    May 16, 2011
    Date of Event
    March 22, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S157
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST THE IMPLANT OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS NOT IN ANY PHYSICAL CONDITION TO RECEIVE A BIVENTRICULAR SYSTEM DUE TO EXHIBITING NEW ISCHEMIA. THE PHYSICIAN AND THE PATIENT CHOSE A CONSERVATIVE PLAN OF CARE AND PLACED A NEW ICD INSTEAD. ON THE ONE MONTH FOLLOW UP VISIT THE DEVICE INTERROGATION SHOWED NORMAL DEVICE FUNCTION AND NO VENTRICULAR EPISODES WERE SEEN. THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION AND CONGESTIVE HEART FAILURE. A CAUSE OF DEATH WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D274DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death