BEUDAMED
    FDA Adverse Event Death Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 3851804 · Received June 5, 2014

    Report

    Report Number
    2017865-2014-13809
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT THE PATIENTS CAUSE OF DEATH WAS ASPIRATION PNEUMONIA, ESOPHAGEAL FOOD BOLUS OBSTRUCTION AND VALVULAR DISEASE. THE DEATH WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS 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
    329168 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death (B)(4)