BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1062110 · Received June 18, 2008

    Report

    Report Number
    3004209178-2008-03332
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001/S15
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEE MANUFACTURING #2182207-2008-02153. THE PT REPORTED THAT SHE WAS FEELING NO STIMULATION FROM HER DEVICE AND HADN'T FELL ANY FOR MONTHS. TROUBLESHOOTING REVEALED THAT THE DEVICE WAS NOT RESPONDING TO THE PT PROGRAMMER. SHE STATES THAT SHE VISITED HER PHYSICIAN AND IT WAS CONFIRMED THAT THERE WAS AN ISSUE WITH HER LEAD AND THOUGH HER DEVICE IS TURNED OFF, SHE FEELS SHOCKING SENSATIONS. THE PHYSICIAN CONFIRMED THAT THE PT HAD BEEN EXPERIENCING LACK OF EFFECT AND NO STIMULATION. THE PT HAD HER IPG AND EXTENSION REPLACED. THE PT HAS RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| IMPLANTED| EXTENSION MODEL 3095