BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2201337 · Received August 3, 2011

    Report

    Report Number
    3004209178-2011-06016
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING OFF AND THERE WAS INTERMITTENT STIMULATION. THE RESULTS FROM IMPEDANCE CHECKS THE PT WAS GETTING QUESTION MARKS (???). IMPEDANCES RUN AT DEFAULT SETTINGS WERE AS FOLLOWS: C-0=???, C-1 =500, C-2=369, 0-1=761, 0-2=749, 0-3=761, 1-2=500, 1-3=605, 2-3=???. IT WAS REPORTED CURRENT FOR 0-1, 0-2, 0-3 WAS LESS THAN 15. IMPEDANCE MEASUREMENTS WITH THESE PAIRS ARE WITH THESE PAIRS ARE WITHIN RANGE. DUE TO PT'S COMFORT THEY COULD NOT INCREASE PAST 1.5V. ALREADY REPROGRAMMED STIMULATION FROM 1-, 2+, 3- TO 1- AND 2+ AND PT STATED THAT MADE A BIG DIFFERENCE IN STIMULATION SENSATION. REPROGRAMMING WAS DONE AROUND THE PARTICULAR ELECTRODE AND THE PT REPORTED BETTER STIMULATION. THE PT WAS INSTRUCTED TO PAY ATTENTION IF HER DEVICE WAS TURNED ON OR OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR LEAD: MODEL 3487A, LOT# L54141| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL004413P| EXTENSION: MODEL 7495-51, LOT# XR0049481N| IMPLANTED: