BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL RIATA

    MDR report key: 7266482 · Received February 12, 2018

    Report

    Report Number
    MW5075195
    Event Type
    Death
    Date Received
    February 12, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 9, 2018
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAD EXTRACTION FOR MALFUNCTION AND EXTERNALIZATION OF CABLES. INAPPROPRIATE SHOCK DUE TO NOISE ON ICD LEAD, (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106372 ST JUDE MEDICAL RIATA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON - CRT) LWS ST. JUDE MEDICAL 7000ST

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| L| R