BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7406668 · Received April 9, 2018

    Report

    Report Number
    3004209178-2018-06732
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    May 15, 2017
    Report Date
    April 9, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS APPROXIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING PROBLEMS WITH BOWEL ACCIDENTS SINCE ABOUT 6 MONTHS AFTER THE DEVICE WAS IMPLANTED. THE PATIENT STATED THEY WEREN¿T AS FREQUENT AS THEY WERE PRIOR TO HAVING THE DEVICE, BUT THEY SEEM TO BE GETTING WORSE. THE PATIENT NOTED THAT THEY THOUGHT THE THERAPY WAS 50% EFFECTIVE. THE PATIENT STATED THAT PRIOR TO THE DEVICE, EVERY TIME THEY¿D GO THEY¿D HAVE AN ACCIDENT. NOW THEY HAD TO HAVE REALLY BAD DIARRHEA IN ORDER FOR THEM NOT TO MAKE IT, AND IT WAS HIT OR MISS. THE PATIENT STATED THEY COULD GO WEEKS OR MONTHS WITHOUT ANY ISSUES, AND THEN WENT 2-3 DAYS IN A ROW AND HAD PROBLEMS. THE PATIENT STATED THAT THEY HAD TRIED INCREASING STIMULATION, BUT IT CAUSED THEIR LEGS TO HURT SO BAD THEY COULDN¿T HANDLE IT SINCE AROUND (B)(6) 2017. THE PATIENT STATED THEY WERE JUMPY, ACHY, AND SORE, AND NOTHING THEY DID TOOK THAT AWAY UNLESS THEY TURNED IT BACK DOWN AGAIN. THE PATIENT STATED THAT THEY HAD IT AT 4.2V AND THEIR HEALTHCARE PROVIDER HAS INSTRUCTED THEM TO NOT CHANGE ANY PROGRAMS, BUT ONLY TO INCREASE STIMULATION. SYNCING WITH THE PROGRAMMER SHOWED THAT STIMULATION WAS ON, AND THE PATIENT WAS ON PROGRAM 1. THE PATIENT HAD THE ABILITY TO CHANGE PROGRAMS OR ADJUST STIMULATION, BUT THEY WERE REDIRECTED TO THEIR HEALTHCARE PROVIDER TO DISCUSS SWITCHING PROGRAMS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249591 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR