BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3191444 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10937
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 093-28, LOT# VA02R42, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013 WHERE NO IMPEDANCE PROBLEMS WERE DETECTED. THE PATIENT STATED THAT THE ¿SHOCKING PAINS¿ WERE RELATED TO THEIR BULGING DISC AND NOT TO ANY PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT ALSO REPORTED TO THE HCP THAT THEY WERE DOING WELL WITH THEIR NOCTURIA (1 TO 2 TIMES PER NIGHT) AND DAYTIME VOIDING (EVERY 2 HRS). IT WAS NOTED THAT THERE WERE NO MORE ¿SHOCKING¿ PAINS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS IN THE ¿WRONG LOCATION¿. THE PATIENT WAS ¿HAVING PROBLEMS¿ AND COULD FEEL A ¿BAD, SHOOTING, CRAMPING PAIN¿ ON HER TAILBONE AND IN THE RIGHT BUTTOCK. THE PAIN ALSO WENT DOWN THE BACK OF THE PATIENT¿S RIGHT LEG, AND HER TOES WERE NUMB. THIS PAIN REPORTEDLY STARTED ON EITHER (B)(6) 2013 OR THE FOLLOWING DAY. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA, UNTIL SHE FELT THE JOLTING THEN. IT WAS NOTED THAT WHEN THE PATIENT FIRST FELT THE JOLT, IT MADE HER FALL AND ¿DROP TO HER KNEES¿. THE PAIN WAS REPORTEDLY ¿SO BAD THAT THE PATIENT HAD TO BE PUT ON A BOARD BECAUSE HER LEGS AND BACK WERE LOCKED UP¿. IT WAS INDICATED THAT THE PATIENT FELT AN OVERSTIMULATION SENSATION. THE PATIENT TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF THE DAY PRIOR TO THE REPORT. THE PAIN PERSISTED AND THE PATIENT COULD STILL FEEL IT AT THE TIME OF THE REPORT BUT IT WAS NOT "AS BAD AS BEFORE". THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND HAD BEEN GOING TO THE BATHROOM ¿A LOT¿ SINCE SHE TURNED THE INS OFF. IT WAS NOTED THAT X-RAYS WERE TAKEN AND NOTHING WAS REPORTEDLY BROKEN. THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH HER HEALTHCARE PROVIDER THE DAY OF THE REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THE PATIENT FELT SHOCKING. THEY HAD A RETURN OF SYMPTOMS AND THEY HAD 2-3 REPROGRAMMING VISITS. THEY FELT IT IN THE LOWER BACK-UPPER BUTTOCK AREA. WHEN THEY WERE STRETCHING OR EXERCISING THEY WOULD FEEL THE SHOCKING. SOMETIMES IT WOULD BE WHEN THEY WERE WALKING OR EVEN SITTING DOING NOTHING. IN 2014 THEY HAD PAIN IN THEIR RIGHT ARM, RIGHT LEG, HIP AND BACK. SHE HAD BEEN HAVING DIATHERMY AND PHYSICAL THERAPY AS WELL. THE PATIENT HAD A FALL AND THEIR DOCTOR WAS NOT NOTIFIED OF IT. THEY PASSED OUT, BROKE HER NOSE, RIB, AND ROTATOR CUFF. THEY FELT AN ELECTRIC SHOCK SINCE THEN IN THE LOWER BACK. IT "FELT LIKE WHEN YOU PUT YOUR HAND IN A LIGHT SOCKET, LIKE A SURGE OF PAIN AND THEN IT WOULD GO AWAY." IT WAS INTERMITTENT AND SOMETIMES THE SHOCK WOULD COME BACK. IT WOULD COME OUT OF NOWHERE. THEY WOULD TURN THE STIMULATION OFF AND THEN LATER TURN IT BACK ON AND SOMETIMES WOULD TRY A DIFFERENT PROGRAM. THE FALL WAS RELATED TO THE ISSUE. DECREASING THE AMPLITUDE DID NOT ELIMINATE THE UNCOMFORTABLE STIMULATION. THE PATIENT WAS IMPLANTED FOR GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289985 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR