BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5429080 · Received February 10, 2016

    Report

    Report Number
    3004209178-2016-02623
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Report Date
    January 18, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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
    85220 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR