BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4081582 · Received September 11, 2014

    Report

    Report Number
    3004209178-2014-16857
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Report Date
    August 15, 2014
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V363145, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# NJ(B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LOSS OF THERAPEUTIC EFFECT, THE LEAD WAS NOT WORKING AND THE OTHER THREE WERE VERY WEAK. THIS STARTED ABOUT SIX MONTHS AGO AND THERE WAS MINIMAL SYMPTOM RETURN. WHEN THE PATIENT WENT OUT TO DINNER SHE HAD TO GO TO THE BATHROOM FOUR TIMES AND SHE HAD TO QUIT TAP DANCE BECAUSE SHE HAD TO GO TO THE BATHROOM SO OFTEN. IF THE PATIENT TURNED STIMULATION UP, SHE WOULD LOSE CONTROL OF HER BOWELS, AND IF SHE HAD IT TOO LOW SHE WOULD GET A ¿HOT SEAT¿ AND ¿ELECTRICAL CHARGE.¿ THE PATIENT ONLY HAD TWO SETTINGS AND THE NURSE SAID THAT THERE SHOULD BE FOUR AND IT WAS TIME TO GET A NEW ONE. IT WAS REPORTED THAT THERE WAS ALSO A PROBLEM WITH THE PATIENT PROGRAMMER, THE LIGHT WAS NOT WORKING, AND SHE WAS NOT ABLE TO CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR. THE PATIENT COULDN¿T MAKE AN ADJUSTMENT EITHER WITH OR WITHOUT THE ANTENNA ATTACHED. THE PATIENT PLANNED TO CONSULT WITH HER HEALTHCARE PROFESSIONAL ABOUT PROGRAMMER REPLACEMENT. 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
    561387 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR