BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4249346 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21554
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 23, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 093-28, LOT# V890309, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. THE PATIENT CALLED BECAUSE THEY NEEDED TO KNOW WHAT WOULD HAPPEN TO THEIR DEVICE OPERATION BECAUSE THEY WERE TAKING A DIURETIC ORDERED BY THEIR CARDIOLOGIST FOR TROUBLE WITH SWELLING IN THEIR LOWER LEGS AND FEET. NO ONE THERE HAD ANY ANSWERS OR SUGGESTIONS AND THE PATIENT HAD FOUND IN THE PAST THAT NO ONE SEEMED TO KNOW MUCH ABOUT THIS DEVICE. THE MANUFACTURER LEFT TOO MUCH INFORMATION TO BE GIVEN BY YOUNG MANUFACTURER REPRESENTATIVES THAT JUST DIDN¿T HAVE THE EXPERIENCE OR TRAINING TO ANSWER IMPORTANT SERIOUS QUESTIONS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD HIGH BLOOD PRESSURE, SHORTNESS OF BREATH, AND SWELLING OF LIMBS, WHICH HAD BEEN GOING ON FOR ABOUT THREE MONTHS. THE PATIENT WAS SEEING A CARDIOLOGIST WHO PRESCRIBED THE DIURETIC HYDROCHLOROTHIAZIDE. SHE WAS CONCERNED THAT THE DIURETIC MAY INTERFERE WITH THE FUNCTIONALITY OF THE DEVICE. THE PATIENT ALSO HAD HIP SURGERY AND GROIN PAIN AND FELT STIMULATION STRONGLY WHEN AT THE CHIROPRACTOR. SHE HAD A LOSS OF THERAPEUTIC EFFECT AND AFTER VARYING AMOUNTS OF TIME HER SETTINGS STOPPED BEING HELPFUL SO SHE WOULD CHANGE PROGRAMS. SHE WOULD LOSE STIMULATION SENSATION AND AFTER THAT SHE WOULD START HAVING PROBLEMS AGAIN, SO NOW SHE PREEMPTIVELY CHANGED PROGRAMS WHEN SHE STOPPED FEELING STIMULATION. THE PATIENT USUALLY HAD STIMULATION NEAR 3.5 VOLTS AND IT GOT UNCOMFORTABLE AT 4 VOLTS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738594 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1