BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2161101 · Received June 17, 2011

    Report

    Report Number
    3004209178-2011-04578
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN THE PAST 2-3 MONTHS, THE PATIENT HAS HAD TO INCREASE STIMULATION TO FEEL, BUT EXPERIENCED A SHOCK SENSATION IN CERTAIN POSITIONS. THE IMPEDANCE MEASUREMENTS WERE NORMAL BUT COMBINATIONS WITH 2 WERE 53 OHMS. THE PATIENT'S CURRENT PROGRAM WAS -1 AND +2 WITH IMPEDANCES AT 1157 OHMS. ALL THE VALUES WERE IN RANGE. THE PATIENT WAS NOT TESTED IN DIFFERENT POSITIONS. THE INS WAS SWITCHED TO 2V AND 3V AND APPEARED TO RECEIVE GOOD STIMULATION AT 2V COMPARED TO PREVIOUSLY NEEDING 8V. IT WAS LATER CONFIRMED THAT THE CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL AND EVERYTHING APPEARED TO BE FINE. A NEW PROGRAM WAS ADDED. THE PATIENT WAS NOT RECEIVING THE COVERAGE HE NEEDED AND WAS GOING TO FOLLOW UP WITH HIS DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0031768N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3587A, LOT# L39241| EXPLANTED: