BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 935288 · Received October 30, 2007

    Report

    Report Number
    2182207-2007-03610
    Event Type
    Injury
    Date Received
    October 30, 2007
    Report Date
    October 3, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P790004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: KESSLER, T.M., ET AL., "SACRAL NEUROMODULATION FOR REFRACTORY LOWER URINARY TRACT DYSFUNCTION: RESULTS OF A NATIONWIDE REGISTRY IN SWITZERLAND" EUROPEAN UROLOGY, (2007) 51: 1357-63. THE ARTICLE DISCUSSES THE TREATMENTS AND OUTCOMES OF 209 PATIENTS. ADVERSE EVENTS WERE RECORDED DURING THE INITIAL TEST PHASE AND/OR DURING OR FOLLOWING TRADITIONS ONE-STAGE TECHNIQUE. AFTER THE IMPLANT OF THE IPG, TWO PATIENTS HAD WOUND INFECTIONS AT THE IPG SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK EZW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R