BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4202391 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20400
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    August 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V639997, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PROGRAMMER WOULD DECREASE BUT WOULD NOT INCREASE THE INTENSITY. THE PATIENT NOTICED THEIR DEVICE WAS OFF ON (B)(6) 2014 WHEN THEY HAD A ROUTINE COLONOSCOPY. IT WAS STATED THE PATIENT DID NOT THINK THEY TURNED THE DEVICE OFF. AT THE TIME OF REPORT, THE PATIENT TRIED TO USE THEIR PROGRAMMER AND ENCOUNTERED POOR COMMUNICATION. IT WAS NOTED THAT REPOSITIONING THE ANTENNA RESOLVED THE POOR COMMUNICATION SCREEN. THE PATIENT SYNCHED WITH THEIR DEVICE AND CONFIRMED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS OFF. THE PATIENT WAS ABLE TO TURN THE STIMULATION ON AND INCREASED THE STIMULATION LEVEL. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682138 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR