BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2791402 · Received October 15, 2012

    Report

    Report Number
    3004209178-2012-09205
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    September 18, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V693903, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION. IT WAS REPORTED THE PATIENT WAS TOO THIN AND THE NEUROSTIMULATOR WORE THROUGH THE SKIN. THE PATIENT HAD SUFFERED A FALL. THE NEUROSTIMULATOR WAS MOVED TO A NEW POCKET AND THE PATIENT WAS DOING FINE.

    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 Required Intervention