BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1842666 · Received September 1, 2010

    Report

    Report Number
    6000032-2010-06664
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MED REL, HUMACAO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    RECEIVED INFO STATING THE PT IS EXPERIENCING HIS STIMULATOR TUNING ITSELF ON WHENEVER HE WALKS BY A REFRIGERATOR. THIS SURPRISES HIM BECAUSE HE DOESN'T EXPECT THE STIMULATION SENSATION TO ALL OF A SUDDEN TURN ON. MEDTRONIC REPRESENTATIVE REPROGRAMMED THE IPG AND WILL DISABLE THE MAGNET SWITCH WHICH SHOULD ELIMINATE UNINTENDED ON/OFF BY MAGNETIC FIELDS. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MED REL, HUMACAO 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR EXPLANTED:| LEAD: MODEL 3586, LOT # LW005747N| EXTENSION: MODEL 7496-51, LOT # YR0014109N| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT # YN0038185P