BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3893584 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12006
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 18, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA0FFXR, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD DIFFICULTY COMMUNICATING WITH THE PROGRAMMER. IT WAS NOTED THE PATIENT CHANGED PROGRAMS THE DAY OF THE CALL AND WAS GOING TO THE BATHROOM ALL OF THE TIME. IT WAS REPORTED THE PATIENT WAS IMPLANTED FOR BOWEL LEAKAGE. IT WAS NOTED THE PATIENT HAD LITTLE BOWEL MOVEMENTS ALL NIGHT LONG AND INCREASED STIMULATION TO HELP WITH THAT. IT WAS REPORTED THE PATIENT HAD DIARRHEA. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS THE FIRST TIME THE PATIENT HAD TURNED OFF THE STIMULATION AND THEY HAD NO LIGHTNING BOLT. THE PATIENT SAW A CHECK MARK WITH THE PROGRAM AND SAW IT IN THE BOOK AND WANTED TO KNOW WHY IT WAS SHOWING THAT. IT WAS NOTED THAT THE PATIENT WAS SET AT PROGRAM 4 AT 0.1V AND THEY ORIGINALLY STARTED AT 2.5V AND HAD TO TURN IT DOWN DUE TO DIARRHEA AND THEY HAD IRRITABLE BOWEL SYNDROME WITH DIARRHEA. IT WAS CONTROLLED WITH IMODIUM AND THE STIMULATOR BROUGHT THE SYMPTOMS BACK. IT WAS REPORTED THAT THE PATIENT HADN¿T BEEN RIGHT SINCE IMPLANT AND MIGHT HAVE BEEN RIGHT FOR A WEEK. THE PATIENT WAS EXHAUSTED AND WAS GOING TO CALL THEIR HEALTH CARE PROVIDER (HCP) TOMORROW TO FOLLOW-UP. IT WAS NOTED THAT THE PATIENT HAD NO GALLBLADDER AND HAD ACID REFLUX AND THEIR GI TRACT WASN¿T THE SAME. IT WAS REPORTED LATER THAT PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS INDICATED THAT SHE TURNED OFF THE STIMULATION ON (B)(6) 2014 AND AT THAT TIME THE HEALTH CARE PROVIDER HAD CHANGED THE CHANNEL. IT WAS INDICATED THAT SHE HAD CRAMPING. IT WAS NOTED THAT SHE TOOK IMODIUM AD A DAY FOR THE IRRITABLE BOWEL SYNDROME (IBS). SHE WAS HAVING LOOSE FORCEFUL BOWEL MOVEMENTS, DIARRHEA AND CRAMPS AND THE INTESTINES WERE IN SPASMS. SHE WAS NOT SURE THAT WAS DUE TO THE IBS OR FROM THE STIMULATOR. IT WAS STATED THAT AFTER THE HEALTH CARE PROVIDER CHANGED THE CHANNEL IT MADE THE SYMPTOMS WORSE. IT WAS INDICATED THAT SHE TURNED OFF THE STIMULATION A WHILE AGO BUT IN THE MORNINGS SHE WAS STILL FEELING THE PULSING AND SHE HAD TO RUN TO HAVE A BOWEL MOVEMENT. IT WAS NOTED THAT PATIENT HAD HISTORY OF IRRITABLE BOWEL SYNDROME. IT WAS REPORTED THAT THERE WAS NO BENEFIT BUT THEN IT WAS HELPING AND SHE WAS ABLE TO FEEL WHEN A STOOL WAS COMING. IT WAS INDICATED THAT PATIENT WAS CURRENTLY ON CURRENTLY ON 1.7 AND HAD VERIFIED STIM POWER WAS OFF. THE PATIENT TURNED STIM TO 0.0 VOLTS AND VERIFIED AGAIN STIM WAS OFF. IT WAS INDICATED THAT PATIENT WILL BE SEEING THEIR HEALTH CARE PROVIDER IN COUPLE OF DAYS AFTER THIS REPORT AND WILL SPEAK TO HIM IF THE CURRENT SYMPTOMS SHE WAS HAVING WAS NORMAL. IT WAS INDICATED THAT PATIENT WAS HAVING INCREASE IN GAS ALL THE TIME SHE WAS DRINKING GINGER ALE AND NOT NORMAL BOWEL MOVEMENTS LIKE IN 3 AND 4 IN THE MORNING AND SHE WAS HAVING AND WHICH WAS DIFFERENT SYMPTOMS THAT WHAT SHE WAS FEELING PRIOR TO THE IMPLANT. IT WAS INDICATED THAT PATIENT WAS THINKING OF WANTING TO HAVE THE DEVICE REMOVED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370259 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR