BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2667656 · Received July 24, 2012

    Report

    Report Number
    3004209178-2012-06032
    Event Type
    Malfunction
    Date Received
    July 24, 2012
    Report Date
    June 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V942569, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1