BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5116997 · Received October 1, 2015

    Report

    Report Number
    3004209178-2015-19130
    Event Type
    Injury
    Date Received
    October 1, 2015
    Report Date
    September 9, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V251861, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED VIA A MANUFACTURING REPRESENTATIVE THAT THE DEVICE WAS REMOVED TWO YEARS AGO WHEN THE PATIENT'S BLADDER WAS REMOVED BECAUSE IT GOT WORSE. IT WAS NOT CLARIFIED WHAT GOT WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651797 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention