BEUDAMED
    FDA Adverse Event Death Summary report: N

    INCEPTA

    MDR report key: 3781356 · Received April 30, 2014

    Report

    Report Number
    2124215-2014-09716
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 31, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WITH THE LOCAL FIELD REPRESENTATIVE AND THE LOCAL AFFILIATE OFFICE, CONFIRMED THE FAMILY MEMBERS HAVE BEEN UNRESPONSIVE. IN ABSENCE OF IDENTIFICATION OF THE HOSPITAL IN WHICH THE PATIENT DIED, NO FURTHER INFORMATION WILL BE RETRIEVABLE. 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 FROM A PATIENT VERIFICATION FORM, THAT THE PATIENT WITH THIS DEVICE PASSED AWAY. AS REPORTED BY A PATIENT ADVOCATE, THE DEVICE FAILED TO TREAT AND RESULTED IN THE PATIENT'S DEATH. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259065 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E160

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death| L E160| 0693