BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4151232 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18481
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0JQ6Q, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_PT M_PROG, SERIAL# UNKNOWN, 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 PAST FEW DAYS THEIR BOWELS WERE DOING THE SAME THING THEY WERE BEFORE THEY GO THE THERAPY. THE PATIENT HAD THE DEVICE FOR BOWEL INCONTINENCE. THE PATIENT WAS NOT FEELING STIMULATION AND NORMALLY THEY FELT IT BUT NOT ALL THE TIME. THE RETURN OF SYMPTOMS WAS SUDDEN AND THE PATIENT KEPT TRYING TO TURN THE STIMULATION BACK ON AND NOTICED A MESSAGE TO CALL THEIR DOCTOR ON THEIR PATIENT PROGRAMMER. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION AND HAD A POWER ON RESET (POR) CONDITION AND THEY NOTICED THE MESSAGE YESTERDAY. THE PATIENT DID END UP TAKING THEIR SPOUSE TO THE HOSPITAL A FEW DAYS AGO CONFIRMING THEY WERE AROUND STRONG SOURCES OF EMI. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632472 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1