BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1111662 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04926
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    January 1, 2003
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SHOCKING SENSATIONS SOON AFTER THE IPG WAS IMPLANTED. THESE SENSATIONS HAVE INCREASED SINCE AND HAPPENED DAILY. THE PT EXPERIENCED THREE SHOCKING SENSATIONS, WHICH CAUSED DISCOMFORT, WHEN THE COMPANY REP INTERROGATED HIS IPG IN 2008. THE PT DIDN'T WANT TO TURN HIS STIMULATOR OFF. HE WAS SATISFIED WITH THE THERAPY'S EFFECT SINCE IT HELPED HIM. THE PT WAS GOING TO SEE IF A LOWER VOLTAGE WOULD AFFECT THE SHOCKING SENSATIONS BEFORE MAKING A DECISION ON HAVING THE SYSTEM REPLACED. FURTHER INFO IS BEING REQUESTED FROM THE HEALTH PROFESSIONAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention EXPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 4351 LOT# NHT001210N| STIM ACCESSORY MODEL 4351 LOT# NHT001209N| IMPLANTED