BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENTRA

    MDR report key: 637947 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06777
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    December 9, 2003
    Report Date
    December 18, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER COLLAPSED AND WAS BROUGHT TO THE HOSPITAL. THE PATIENT WAS ASYSTOLIC AND PACING OUTPUT WAS NOT SEEN ON A SURFACE ELECTROCARDIOGRAM. ATTEMPTS TO REVIVE THE PATIENT WERE UNSUCCESSFUL. THE DEVICE WAS IN SERVICE FOR OVER 5.5 YEARS AND HAD NOT BEEN INTERROGATED OR EVALUATED SINCE BEING IMPLANTED. THE PACEMAKER WAS LATER INTERROGATED AND THE REPORTED BATTERY STATUS OF ELECTIVE REPLACEMENT PAST (ERP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTRA IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death