BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 4317332 · Received December 3, 2014

    Report

    Report Number
    MW5039435
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 19, 2014
    Report Date
    November 19, 2014
    Manufacturer
    ST. JUDE
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING ST. JUDE MEDICAL CERVICAL DORSAL COLUMN STIMULATOR, SURGICALLY REMOVED, FRACTURED LEAD NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781228 ST. JUDE MEDICAL CON MINI STIMULATOR LGW ST. JUDE 3788

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR