BEUDAMED
    FDA Adverse Event Death Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 2863054 · Received December 10, 2012

    Report

    Report Number
    2017865-2012-10521
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    November 16, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND DECEASED IN HIS HOME. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL SUGGESTING THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death (B)(4)