BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY

    MDR report key: 6044928 · Received October 20, 2016

    Report

    Report Number
    2124215-2016-17413
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    March 13, 1996
    Report Date
    October 3, 2016
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    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 A CALL FROM THE PATIENT'S MOTHER IN (B)(6) 2016 REPORTING THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER PASSED AWAY IN (B)(6) 1996 (OVER 20 YEARS AGO). THE CALLER STATED THE PATIENT HAD PNEUMONIA AND HER PACEMAKER STOPPED WORKING. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS THE FIRST TIME BOSTON SCIENTIFIC BECAME AWARE OF THE PATIENT'S DEATH. THE PACEMAKER WAS NEVER RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696408 RELAY IMPLANTABLE PULSE GENERATOR DXY GUIDANT ANGLETON/ST. PAUL 294-03

    Patients

    Seq Age Sex Outcome Treatment
    1 14211 DA Death 294-03| 439-04| 439-07