BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4534529 · Received February 23, 2015

    Report

    Report Number
    3004209178-2015-03478
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Report Date
    February 3, 2015
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V913913, IMPLANTED: 2012-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PT M_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT HAD BEEN ALMOST 2 YEARS SINCE THE PATIENT GOT IMPLANTED AND SHE WAS STILL LOOSING STOOL, IT DOES NOT STOP. THE PATIENT SAID 'I DO KNOW WHEN STOOL COMES OUT AND IF IT IS FIRM AND IF IT IS NOT I DO NOT KNOW'. THE PATIENT TRIED INCREASING STIM TO 1.75 V SOMETIME IN DECEMBER 2014. 1.75 V FELT TOO MUCH AND THE PATIENT DECREASED IT TO 1.50 V. THE PATIENT FELT NO STIM AT 1.50 V. ONE DAY, ON (B)(6) 2015, SHE WAS RUNNING ERRANDS AND HER STOOLS WERE FALLING OUT, SHE HAD TO COME BACK HOME AND CHANGE CLOTHES. THE PATIENT GOT SO AGGRAVATED AND TURNED THERAPY OFF. THERAPY WAS CURRENTLY OFF. THE PATIENT WAS (B)(6) YEARS OLD AND CONCERNED IT WAS GOING TO GET WORSE AS SHE GETS OLDER: THE PATIENT WILL BE WALKING WITH A WALKER AND DROPPING STOOL AND SOMEONE WILL HAVE TO GO BEHIND AND CLEAN IT. THE PATIENT HAD NOT NOTIFIED HCP (HEALTHCARE PROVIDER) YET. THE PATIENT WAS AFRAID HE WAS NOT GOING TO BE HAPPY THAT SHE TURNED THERAPY OFF. THE PATIENT ONLY FELT STIM BETWEEN LEG AND VAGINA BUT NOT IN RECTUM. THE PATIENT HAD NOT TRIED OTHER PROGRAMS YET. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT NOTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. NO OUTCOME WAS 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A 50 PERCENT OR GREATER SYMPTOM REDUCTION. THE EVENT CAUSE WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS RELATED TO THE DEVICE. REPROGRAMMING WAS NEEDED. THE PATIENT DID NOT EXPERIENCE A LOSS OF THERAPEUTIC EFFECT OR A LOSS OF STIMULATION. ON (B)(6) 2012 THE PATIENT HAD A FOLLOW-UP APPOINTMENT WITH HER HEALTHCARE PROVIDER, THINGS WERE COMING ALONG NICELY, AND SHE HAD NO EPISODES OF INCONTINENCE. AT THE PATIENT'S SIX-MONTH FOLLOW-UP, SHE STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING. SHE HAD TRIED SEVERAL PROGRAMS BUT NONE OF THEM WORKED. A REVIEW OF HER HISTORY NOTED ANXIETY, TWO TO THREE FORMED BOWEL MOVEMENTS PER WEEK (FROM FIVE TO SIX) WITH ONE EPISODE OF MINOR STAINING PER WEEK, THE PATIENT RANDOMLY CHANGED HER PROGRAM WITHOUT CONTACTING A MANUFACTURER REPRESENTATIVE, AND SHE HAD TWO MINOR EPISODES OF URGENCY A WEEK. ON (B)(6) 2013 THE PATIENT HAD A FOLLOW-UP VISIT WITH HER HEALTHCARE PROVIDER AFTER HAVING A COLONOSCOPY. SHE HAD MINIMAL INCONTINENT EPISODES. THE PATIENT'S SURGICAL INCISIONS WERE WELL-HEALED, SHE HAD A LOW-PROFILE INS, THE INS WAS IN PLACE, AND NO INFECTION WAS NOTED. THE WIRES WERE INTACT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124937 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR