BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERLITH

    MDR report key: 930003 · Received October 19, 2007

    Report

    Report Number
    2124215-2007-99793
    Event Type
    Death
    Date Received
    October 19, 2007
    Date of Event
    July 1, 1979
    Report Date
    October 16, 2007
    Manufacturer
    ITM
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. EVENT CONCLUSION THE DEVICE WAS NEVER RETURNED FOR TESTING. THEREFORE, BSC CRM COULD NOT CONFIRM ANY ALLEGATIONS AGAINST THIS DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS EVENT WILL BE RE-EVALUATED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION ACCORDING TO OUR BOSTON SCIENTIFIC (BSC) CRM MEDICAL RECORDS DEPARTMENT, THE PATIENT WHO HAD BEEN IMPLANTED WITH THIS PACEMAKER DIED IN 1979 DUE TO AN UNREPORTED CAUSE. ON SEPTEMBER 17, 2007 BSC CRM RECEIVED INFORMATION FROM THIS PATIENT'S FAMILY STATING THAT THEY SUSPECT THE PATIENT'S DEVICE DID NOT WORK APPROPRIATELY AND THEY BLAME THE HOSPITAL FOR THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLITH IMPLANTABLE PULSE GENERATOR DXY ITM 224-01

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death