BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2102643 · Received May 23, 2011

    Report

    Report Number
    3004209178-2011-03733
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 27, 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

    THE PT NOTICED A LOSS OF STIMULATION ABOUT (B)(6) AGO AND STATED THAT STIMULATION WAS TURNING OFF. A MFR'S REP MET WITH THE PT AND REPORTED A POWER ON RESET (POR) CONDITION. THE REP MEASURED THE IMPEDANCES AND FOUND THE NEUROSTIMULATOR BATTERY WAS OKAY. REPROGRAMMING WAS PLANNED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 40 YR IMPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF012347N| EXPLANTED:| LEAD: MODEL 3988, LOT# N24015| PROGRAMMER: MODEL 7434, LOT# YN0034901P| EXPLANTED:| IMPLANTED: