BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1427973 · Received May 6, 2009

    Report

    Report Number
    3004209178-2009-03201
    Event Type
    Malfunction
    Date Received
    May 6, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 9, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE PT WAS IN A CAR ACCIDENT AND THEN HAND AN MRI. THE PT FELT PULLING AND TUGGING WHEN ENTERING THE MRI ROOM. FOLLOWING THIS, THE PT HAD TO HAVE THE VOLTS UP TO 9.5 IN ORDER TO FEEL STIMULATION. THE PT FELT 25% STIMULATION IN HIS LEFT ARM AND 75% IN HIS RIGHT ARM; BEFORE THE EVENT, HE ONLY FELT STIMULATION IN HIS RIGHT ARM. IMPEDANCES WERE CHECKED AND WERE REPORTED TO BE FINE. WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SET AT PW 390, RATE 31, VOLTS 4.1, 1- AND 2+, THE PT FELT NOTHING UNTIL THEY RAMPED THE VOLTS UP TO 9.5 VOLTS. BUT IF THEY PROGRAMMED TO 0-, 1-, 3+, 2+, PW 210, RATE 25, THE PT COULD FEEL STIMULATION AT 2.5 VOLTS; THAT WAS WHEN HE WAS GETTING THE STIMULATION IN THE RIGHT AND LEFT ARM. THE INS WAS REPROGRAMMED, AND THE PT RECEIVED ADEQUATE STIMULATION IN HIS AFFECTED PAINFUL AREAS. THE PHYSICIAN ADVISED THE PT TO RETURN TO HIS OFFICE IF HE EXPERIENCED ANY ADDITIONAL PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LEAD: MODEL 3888| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51| PROGRAMMER: MODEL PROGRAMMER