BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2030905 · Received March 4, 2011

    Report

    Report Number
    3004209178-2011-01645
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    August 1, 2010
    Report Date
    February 14, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND SOMETIMES HAD A SHOCKING SENSATION. HE KEPT THE NEUROSTIMULATOR AT A LOW SETTING AND DID NOT ALWAYS FEEL THE STIMULATION. ABOUT 6 MONTHS AGO HE STARTED HAVING PAIN IN THE BACK. WHEN HE TRIED TO USE HIS PT PROGRAMMER HE ONLY SAW THE 9V LIGHT (EVEN AFTER REPLACING WITH A NEW 9V BATTERY). ADDITIONAL INFO WAS 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 55 YR LEAD: MODEL 3998, LOT# L58930| IMPLANTED:| EXTENSION: MODEL 7498, LOT# NED004781N| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0034410P| IMPLANTED: