BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 1696023 · Received May 24, 2010

    Report

    Report Number
    2124215-2010-11377
    Event Type
    Death
    Date Received
    May 24, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE PACEMAKER HAS NOT BEEN RETURNED. IF THIS PACEMAKER SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT RECENTLY PASSED AWAY. THE PATIENT'S DAUGHTER CALLED BOSTON SCIENTIFIC PATIENT SERVICES AND STATED THAT HER MOTHER PASSED AWAY, AND THE DEVICE DID NOT DO ANYTHING TO GET HER HEART GOING AGAIN. TO DATE, THERE HAS BEEN NO CAUSE OF DEATH IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR DXY GUIDANT CRM CLONMEL IRELAND S201

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death 4046| H175| (B) (4)| 4518| 4402| 0175| S201| 4513