BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTREL 3

    MDR report key: 2092983 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03247
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    January 1, 2000
    Report Date
    April 11, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING JOLTING SENSATIONS AT THE LEAD LOCATION THAT WERE CHARACTERIZED AS 'SURGE(S) IN THE BACK AREA WHERE THE TINGLING IS" SINCE THE STIMULATOR WAS IMPLANTED. A REPROGRAMMING WAS PERFORMED WITH THE PATIENT IN DIFFERENT POSITIONS, BUT THE ISSUE WAS NOT RESOLVED. THE PATIENT DID NOT WANT TO USE STIMULATION WHILE "UP AND ABOUT" DUE TO THE JOLTING SENSATIONS. IT WAS UNCLEAR WHETHER THE JOLTING SENSATIONS WERE DUE TO NORMAL POSTURAL SHIFT CHANGES. IMPEDANCE READINGS WERE NORMAL. IT WAS INDICATED TH THAT THE PATIENT DID NOT WANT A REVISION, WAS STILL IN PAIN FOR WHICH MEDICATION WAS BEING ADMINISTERED, AND STILL OCCASIONALLY USED THE STIMULATION IF STAYING IN THE SAME POSITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR IMPLANTED:| LEAD: MODEL 3587A, LOT# L83871| EXTENSION: MODEL 7495-51, LOT# XR0078877N| IMPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0044262P