BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4508477 · Received February 11, 2015

    Report

    Report Number
    3004209178-2015-02846
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    May 1, 2014
    Report Date
    January 27, 2015
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V841549, IMPLANTED: 2011 (B)(6); 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 HAD A LOSS OF THERAPEUTIC EFFECT, AND THE DEVICE DID NOT ¿SEEM TO BE WORKING.¿ THE DEVICE REPORTEDLY WORKED ¿EVERY NOW AND THEN,¿ BUT THE PATIENT COULD NOT FEEL ANY STIMULATION OR TINGLING AFTER TURNING THE SETTINGS UP AS HIGH AS POSSIBLE AND PROGRAMS WERE CHANGED. THE PATIENT¿S BLADDER REPORTEDLY WOKE HER UP AT NIGHT AND WAS ¿DEAD.¿ PATIENT OUTCOME AND ACTIONS TAKEN WERE NOT REPORTED. FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102583 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR