BEUDAMED
    FDA Adverse Event Death Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 6210206 · Received December 28, 2016

    Report

    Report Number
    2017865-2016-08040
    Event Type
    Death
    Date Received
    December 28, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 3, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DECEASED FROM CARDIOPULMONARY ARREST, CARDIOMYOPATHY AND CORONARY ARTERY DISEASE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860006 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5386 0002122942

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death (B)(4)| (B)(4)