BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1062121 · Received June 18, 2008

    Report

    Report Number
    3004209178-2008-03324
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 20, 2008
    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
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT A MONTH BEFORE THE PT HAD BEEN WALKING UP THE STAIRS AND RECEIVED A JOLT FROM HER NEUROSTIMULATOR (INS). SINCE THEN THE PT FEELS LIKE THE INS IS CONSTANTLY RUNNING, EVEN IF SHE TURNS OFF THE SYSTEM WITH HER PROGRAMMER SHE CAN FEEL IT RUNNING. THE PT ALSO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, SURGING OR FADING SENSATION, AND PAIN IN HER RIGHT LEG/FOOT AND AT THE INS SITE. NO PT TREATMENT OR OUTCOME WAS REPORTED. THE PT'S STATUS WAS REPORTED AS FAIR.

    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 Required Intervention PROGRAMMER MODEL 7434 LOT# YN0047524P| LEAD MODEL 3888 LOT #J0564051V| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU104623V| EXPLANTED:| IMPLANTED:| EXPLANTED: