BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3412524 · Received October 16, 2013

    Report

    Report Number
    3004209178-2013-19146
    Event Type
    Injury
    Date Received
    October 16, 2013
    Report Date
    October 15, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V813549, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ABOUT ONE MONTH PRIOR TO REPORT THE DEVICE BEGAN SHOWING THROUGH RIGHT UNDER PATIENT¿S SKIN TO THE POINT OF BEING ABLE TO PROBABLY SEE THE SERIAL NUMBER OFF OF THE IMPLANTED DEVICE. REPORTEDLY, NO DOCTOR WOULD ¿TOUCH THE DEVICE.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS ABLE TO CONNECT WITH THE PATIENT AND DISCUSSED HER CURRENT NEED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED. THE PATIENT WAS REFERRED TO A SURGEON THAT TAKES MEDICAID AND THE PATIENT WAS SCHEDULED FOR A CONSULT. PLEASE REFER TO MFG. REPORT #S 3004209178-2013-15780, 3004209178-2013-15798, AND 3004209178-2013-02800; AS THE PATIENT HAD MULTIPLE ISSUES WITH THE INS. IT WAS UNKNOWN WHICH EVENT (S) LEAD TO THE ULTIMATELY REMOVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530116 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention