BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7556906 · Received May 31, 2018

    Report

    Report Number
    3004209178-2018-12217
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Report Date
    May 31, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT WAS SEEN TWO WEEKS AGO DUE TO THE STIMULATION NOT WORKING (AFTER THE FALL). THE HCP STATED THAT THE PATIENT HAD A FALL. THE HCP REPORTED THAT AFTER THE REPROGRAMMING, THE PATIENT WAS GETTING GOOD RELIEF, 50% ON PROGRAM 1, BUT IT ONLY LASTED ABOUT 1 WEEK. THE HCP STATED THAT AT THAT TIME ((B)(6)), IMPEDANCE WAS DONE, SHE DID NOT HAVE THE IMPEDANCE READINGS, BUT SHE DID RECALL THAT CONTACT 0-3 WERE SHOWING HIGH VALUES, SHE DID NOT RECALL THE OHMS VALUES. THE HCP DID NOT RECALL WHICH ELECTRODE WAS BEING USED ON PROGRAM 1. THE HCP NOTED THAT SHE HAD INTERROGATED THE DEVICE PRIOR TO CALLING, AND THAT SHE SHIFTED FROM PROGRAM 1 TO PROGRAM 2. THE PATIENT WAS SEEN THE DAY OF THE CALL. THE PATIENT WAS ONLY FEELING STIMULATION ON THE RIGHT BUTTOCKS. THE HCP REPORTED THAT THE PATIENT SYMPTOMS WERE GETTING WORSE, AND THAT THE PATIENT FELT A STRONG URGENCY TO URINATE (STARTED BEFORE THE FALL) AND KEPT WETTING HER PANTS. ELECTRODE IMPEDANCE TESTED ON PROGRAM 2: 1V/210PW: C0: 1147 OHMS, C1:1111 OHMS, C2:1147 OHMS, C3:1185 OHMS, 01: 1546 OHMS, 02: 2213 OHMS, 03: 2213 OHMS, 12: 2085 OHMS, 13: 2213 OHMS, 23: 2213 OHMS, THRESHOLD TESTING DONE USING ELECTRODES: 3+2- 210PW/14HZ. PATIENT FEELS STIMULATION ON HER RIGHT BUTTOCK AT 1.2V 3-2+ 210PW/14HZ. PATIENT FEELS STIMULATION ON HER RIGHT BUTTOCK AT 1.3V 0-1+ 210PW/14HZ. PATIENT FEELS STIMULATION ON HER RIGHT BUTTOCK AT 0.5V. C+1- 210PW/14HZ. PATIENT FEELS STIMULATION ON HER RIGHT BUTTOCK AT 0.7V C+2- 210PW/14HZ. PATIENT FEELS STIMULATION ON HER RIGHT BUTTOCK AT 0.6MA C+3- 210PW/14HZ. PATIENT FEELS STIMULATION ON HER RIGHT BUTTOCK AT 0.7MA C+0- 210PW/14HZ. PATIENT FEELS STIMULATION ON HER RIGHT BUTTOCK AT 0.3MA THE HCP WAS DIRECTED TO THE MANAGING HCP BECAUSE THE PATIENT ONLY FELT STIMULATION ON HER RIGHT BUTTOCK LOCATION. NO FURTHER COMPLICATIONS WERE ANTICIPATED/REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400112 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1