BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7218996 · Received January 25, 2018

    Report

    Report Number
    3004209178-2018-01362
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    January 10, 2018
    Report Date
    January 25, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INTERNAL NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR IT WAS REPORTED THAT THE PATIENT STATED HER STIMULATOR WAS VIBRATING. PATIENT WAS REFERRING TO NORMAL STIMULATION AS VIBRATION AND PATIENT STATED IT¿S ALMOST LIKE HER STOMACH WAS GROWLING LIKE THE STOMACH VIBRATED. PATIENT STATED SHE HAD NOT TRIED TURNING HER DEVICE OFF YET BECAUSE SHE HAD IT ON THE SAME PROGRAM FOR A LONG TIME AND PATIENT HAD NOT TROUBLE WITH IT. PATIENT STATED ALL OF A SUDDEN LIKE TWO WEEKS AGO, IT STARTED VIBRATING AND THOUGHT IT WOULD GO AWAY BUT HAD NOT STOPPED. PATIENT STATED SHE FELT LIKE VIBRATION IN THE LOWER PART OF HER STOMACH ALL THE WAY DOWN TO HER BUTT AREA. PATIENT STATED IT VIBRATED LIKE ¿ZZZ¿. PATIENT HAD SOMEONE PUT HER HAND ON HER STOMACH AND THEY COULD FEEL THE VIBRATION FROM THE OUTSIDE, PATIENT STATED THIS DID NOT HAPPEN ALL THE TIME AND THAT IT HAPPENED LIKE ONCE AN HOUR FOR 50 SECONDS AND STOPPED. PATIENT SYNCHED WITH PATIENT PROGRAMMER AND IT SHOWED IMPLANT WAS ON AND WAS ON P1 AT 18V. PATIENT TURNED STIM OFF AND IT WAS REVIEWED WITH THE PATIENT HOW TO TURN IMPLANT BACK ON. PATIENT REPORTED SHE HAD NO FALLS, BUT DOES EXERCISE. PATIENT STATED SHE RUNS 3 AND A HALF MILES A DAY AND HAD A TRAINER THAT TRAINS HER EVERY DAY. PATIENT WAS ADVISED TO LEAVE DEVICE OFF FOR A FEW HOURS AND THEN MONITOR IF VIBRATION STILL OCCURRED WITH DEVICE OFF. PATIENT WAS ADVISED TO WRITE DOWN HOW OFTEN OCCURRED AND FOLLOW UP WITH HEALTHCARE PROFESSIONAL (HCP) TO GET DEVICE CHECKED. NO SYMPTOMS REPORTED. NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62743 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR