BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6616330 · Received June 6, 2017

    Report

    Report Number
    3004209178-2017-11755
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    December 16, 2016
    Report Date
    January 4, 2019
    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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT#: VA1C1FC, PRODUCT TYPE: LEAD. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS INDICATED THAT THE PATIENT EXPERIENCED A LOSS OR CHANGE IN THERAPY. THE PATIENT REPORTED THAT THE IMPLANT WAS OK FOR A WHILE AND THEN IT STARTED ACTING UP WHILE THEY WERE OVERSEAS. THE PATIENT NOTED THAT THEY WERE EXPERIENCING INCONTINENCE AND WERE GOING TO THE BATHROOM EVERY HALF HOUR, THEN EVERY 2 HOURS. IT WAS INDICATED THAT THIS WAS ERRATIC. THE PATIENT NOTED THAT THEY WENT TO A HEALTH CENTER IN MADRID BECAUSE OF THIS AND THAT THEY HAD A PIECE OF WIRE STICKING FROM THEIR BACK, MAYBE 1 MM. THE PATIENT NOTED THAT IT WAS BOTHERING THEM WHEN THEY MOVED AND NOTED IT WAS LIKE A PINCHING OR SOMETHING. THE PATIENT STATED THAT THE OVERSEAS DOCTOR CUT THE LITTLE PIECE OFF. THE PATIENT NOTED THAT IT MAY HAVE BEEN THE LEAD BUT IT WAS 5 OR 6 INCHES FROM THEIR IMPLANT TO THE LEFT. WHEN THE PATIENT CAME BACK FROM BEING OVERSEAS THEY SAW THEIR HEALTHCARE PROFESSIONAL (HCP) AND AN X-RAY WAS TAKEN OF THE WHOLE AREA. THE PATIENT NOTED THAT THEY HAD NOT HEARD ANYTHING ELSE FROM THE HCP, SO THEY TALKED TO THEIR GERIATRIC DOCTOR. THE PATIENT STATED THAT THEIR GERIATRIC DOCTOR WAS GIVEN THE X-RAY RESULTS AND THAT THE RESULTS STATED LEAD PLACEMENT IS NOT COMPARED TO INITIAL STUDY AND LEAD EXTENDS INTO PELVIS. THE PATIENT REPORTED THAT BECAUSE OF THE INCONTINENCE THEY HAD BEEN UNABLE TO SWIM AND BECAUSE OF NOT BEING ABLE TO SWIM THEY WERE IN PAIN FROM THEIR ARTHRITIS. THE PATIENT NOTED THAT WHEN THEY SWAM THE ARTHRITIS PAIN WAS PRACTICALLY NIL. THE PATIENT STATED THAT THE ARTHRITIS PAIN WAS RELATED TO THE THERAPY BECAUSE THEY COULD NOT SWIM. THE PATIENT WASN'T EXERCISING BECAUSE THEY DIDN'T WANT THE PATIENT PEEING IN THE POOL. THE PATIENT NOTED THAT THEY HAD ALWAYS HAD ARTHRITIS IN THEIR KNEES BUT BEING UNABLE TO SWIM SINCE THE NEW DEVICE WAS IMPLANTED WAS CAUSING THEM TO HAVE ARTHRITIS PAIN. NO FURTHER COMPLICATIONS WERE REPORTED OR WERE EXPECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT SHE WAS STILL HAVING ISSUES GETTING UP TO GO TO THE BATHROOM AND THAT THE ISSUE HAS NOT BEEN ADDRESSED. SHE HAD BEEN DEALING WITH IT AND WAS WONDERING WHAT SHE WOULD DO TO IMPROVE THINGS. PATIENT SERVICES WALKED THE PATIENT THROUGH INCREASING STIMULATION FROM P2- 2.9V TO P3-3.5V. SHE CONFIRMED COMFORTABLE STIMULATION WAS FELT IN BIKE SEAT. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. CONSUMER REPORTED THE PAIN WAS CAUSED BY ARTHRITIS AND THAT THE PROTRUDING WIRE WAS CUT OFF BY A PHYSICIAN IN (B)(6). THEY ALSO HAD REPROGRAMMING DONE. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394944 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR