BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFIRM

    MDR report key: 3250933 · Received July 29, 2013

    Report

    Report Number
    2017865-2013-05036
    Event Type
    Death
    Date Received
    July 29, 2013
    Date of Event
    December 27, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST, RESPIRATORY FAILURE AND DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352410 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DM2102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death