BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4083809 · Received September 12, 2014

    Report

    Report Number
    3004209178-2014-16887
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    May 30, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V941222, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2014. (B)(4).: IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND DIDN¿T FEEL THE STIMULATION AS MUCH AS BEFORE. THREE DAYS AGO THE PATIENT NOTICED THAT STIMULATION HAD STOPPED AND THEY HAD SOME ISSUES. IT WAS NOTED THAT THE PATIENT CHECKED THE PATIENT PROGRAMMER BATTERIES AND THEY WERE LOW SO THE PATIENT CHANGED THE BATTERIES AND HAD TO INCREASE STIMULATION TO REALLY FEEL IT. THE PATIENT WAS AT 1.5V AND WASN¿T FEELING IT AND NOTICED THAT THEY WEREN¿T ABLE TO MAKE IT TO THE BATHROOM AND THOUGHT THAT¿S WHY THEY WEREN¿T FEELING STIMULATION. IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE FOR THEIR BOWELS AND NOW HAD DOUBLE THE AMPLITUDE. THE PATIENT HAD BEEN OKAY AND WAS NOT SCHEDULED TO SEE THEIR HEALTH CARE PROVIDER (HCP) UNTIL NEXT MONTH IN JULY. IT WAS NOTED THAT THE PATIENT ALWAYS FELT SOMETHING AND IN THE PAST 2 DAYS HAD TO RUSH TO THE BATHROOM. THE PATIENT WAS ON PROGRAM 2 AT 2.6V AND WAS HARDLY FEELING IT AND THEY WERE AT 1.3V OR 1.4V BACK IN NOVEMBER. IT WAS REPORTED THAT THE PATIENT WOULD TRY TO INCREASE STIMULATION TO A COMFORTABLE LEVEL AND WOULD POTENTIALLY CHANGE PROGRAMS IF NEEDED. IT WAS FURTHER REPORTED THAT THE PATIENT WANTED TO KNOW HOW TO CHANGE PROGRAMS USING THEIR PROGRAMMER AND CHANGED FROM PROGRAM 2 TO PROGRAM 3. THE PATIENT WAS NOT ABLE TO FEEL ANY STIMULATION ON PROGRAM 3 SO THEY CHANGED BACK TO PROGRAM 2. THE PATIENT STARTED OUT AT 1.4V ON PROGRAM 2 BUT WASN¿T FEELING STIMULATION SO THEY HAD TO KEEP BUMPING IT UP AND THEY WOULD BE OK AND FELT IT SLIGHTLY AND THEN SOMETHING WENT HAYWIRE AND THE PATIENT FELT PAIN. THE SYMPTOMS OCCURRED SUDDENLY AND THE PATIENT SAW THEIR HCP ABOUT THEIR PROBLEMS IN (B)(6) AND THEY TOOK AN X-RAY. THE PATIENT WENT BACK TO THEIR HCP LAST WEEK BUT THEY WANTED TO DISCUSS THE RESULTS OF THE X-RAY WITH THE MANUFACTURER REPRESENTATIVE AND THE PATIENT WOULD FOLLOW-UP AGAIN IN (B)(6). THE PATIENT WANTED TO KNOW WHAT WOULD HAPPEN IF THERE WAS A PROBLEM WITH THE LEAD. 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
    564694 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR