BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2193401 · Received July 13, 2011

    Report

    Report Number
    6000032-2011-05374
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    January 1, 2006
    Report Date
    June 17, 2011
    Manufacturer
    MDT PUERTO RIO OPERATIONS CO., MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS "BURNED OUT" FOLLOWING AN MRI IN 2006. THE DEVICE WAS STILL IMPLANTED AT THE TIME OF REPORT AND THE PT WAS TREATING HIS PAIN WITH ORAL MEDICATION. THE PT WAS GOING TO FOLLOW UP WITH HIS PHYSICIAN REGARDING A POSSIBLE EXPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR LEAD: MODEL 3487A, LOT# L59055| IMPLANTED:| EXTENSION: MODEL 7498, LOT# NED003844N| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0028975P| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# L59055| EXPLANTED: