BEUDAMED
    FDA Adverse Event Death Summary report: N

    DYNAGEN

    MDR report key: 6145300 · Received December 5, 2016

    Report

    Report Number
    2124215-2016-20311
    Event Type
    Death
    Date Received
    December 5, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 15, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION A CALL FROM THE PATIENT'S SISTER-IN-LAW REPORTING THAT THE PATIENT PASSED AWAY DUE TO COMPLICATIONS WITH INFECTION, KIDNEY STONES, AND CONGESTIVE HEART FAILURE. THE CALLER REPORTED THAT THE PATIENT'S HEART RATE DROPPED AND HE WAS UNABLE TO BE RESUSCITATED. THE PATIENT WAS GOING TO BE CREMATED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE DEVICE WILL NEED TO BE REMOVED AND DISCUSSED HAVING THE FUNERAL HOME RETURN THE DEVICE TO BOSTON SCIENTIFIC. THE SOURCE OF THE INFECTION WAS NOT PROVIDED AND IT IS NOT KNOWN IF THE INFECTION SEEDED TO THE DEVICE OR LEADS. THE FIELD REPRESENTATIVE WAS CONTACTED BUT WAS NOT AWARE OF THE CIRCUMSTANCES REGARDING THE PATIENT'S DEATH AND WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795285 DYNAGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND D152

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death 0293| 7740| 7741| D152