BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2061824 · Received April 4, 2011

    Report

    Report Number
    9614453-2011-02527
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    August 2, 2007
    Report Date
    February 4, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. TRAINING IS IN PLACE.

    Description of Event or Problem · 1

    RECEIVED INFORMATION, THE PATIENT HAD A LEAD REVISION FROM A PERCUTANEOUS LEAD TO A SURGICAL LEAD. (REASON FOR REVISION IS NOT KNOWN). DURING FOLLOW UP REPROGRAMMING, IT WAS REPORTED THE NURSE SWITCHED THE IMPLANTABLE NEURO STIMULATOR ON BEFORE CLEANING THE PROGRAMMED STIMULATION SETTINGS. WITH THE PERCUTANEOUS LEAD, THE PATIENT HAD BEEN USING A HIGH AMPLITUDE, WHICH WAS STILL SHOWING ON SCREEN. THEREFORE, THE PATIENT WAS STIMULATED WITH A VERY HIGH PAINFUL LEVEL OF STIMULATION AND BECAME VERY DISTRESSED. THE NURSE PANICKED AND WAS NOT ABLE TO SWITCH THE STIMULATOR OFF BECAUSE SHE COULD NOT ESTABLISH GOOD CONTACT BETWEEN THE PROGRAMMER HEAD AND THE INS. A COLLEAGUE HAD TO SWITCH THE INS OFF BY USING ANOTHER PROGRAMMER. THE PATIENT WAS TRAUMATIZED FROM THIS EVENT. A SECOND INCIDENT OCCURRED WITH THIS PATIENT (REFERENCE MFR REPORT # 9614453-2008-04818), BUT THE IPG WAS EXPLANTED AND ANALYSIS CONFIRMED NO ABNORMALITIES. IT WAS SUGGESTED THE PATIENT MAY BE FEARFUL/OVERSENSITIVE TO STIMULATION DUE TO THE ORIGINAL INCIDENT AND PSYCHOLOGICAL FACTORS MAY HAVE BEEN INVOLVED. PATIENT WAS TRAUMATIZED BY THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC EUROPE SARL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL 8840, LOT# NHF026408N