BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN INTERSTIM

    MDR report key: 3970281 · Received July 31, 2014

    Report

    Report Number
    3007566237-2014-02132
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447119 UNKNOWN INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1