BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3980760 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13963
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0H3LQ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION AND WHEN THEY TURNED STIMULATION UP THEY GOT 3 THROBS LIKE VERY STRONG SHOCKS AND THEN NOTHING. THE PROGRAMMER WAS SET AT 3.5V BUT THE PATIENT USUALLY DIDN¿T GO ABOVE 1 SOMETHING. IT WAS NOTED THAT THE PATIENT¿S URINARY PROBLEMS WERE GOING DOWNHILL FAST AND THEIR URGENCY WAS INCREASING AGAIN. THE PATIENT ALLEGED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) INCREASED THE STIMULATION ON ITS OWN. IT WAS REPORTED THAT THE PATIENT¿S SYMPTOMS HAD A GRADUAL ONSET AND THE STIMULATION WAS FINE AFTER A REPROGRAMMING AT THEIR HEALTH CARE PROVIDER¿S (HCP¿S) OFFICE ON (B)(6) 2014. THE PATIENT USED THEIR PROGRAMMER TO CHANGE THE SETTING AT SOME POINT. IT WAS STATED THAT THE PATIENT GOT STIMULATION TO 3.2V AND THE 3 THROBS STARTED AND THEN THE PATIENT INCREASED TO 3.5V. THE PATIENT COULD NOT DECREASE THE STIMULATION WITH THE PATIENT PROGRAMMER. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO DECREASE THE STIMULATION TO 1.7V AND THE 3 THROBS FELT LESS INTENSE AND THEY MENTIONED THAT THE STIMULATION SHOULD BE CONSTANT AND THROBBING. THE PATIENT THOUGHT THEY WERE ON PROGRAM 3 AND THEY WERE ACTUALLY ON PROGRAM 4 AT 1.9V. IT WAS NOTED THAT THE PATIENT DID NOT INCREASE THE STIMULATION FROM 1.7V AND THEN INCREASED TO 2.0V. IT WAS STATED THAT THE PATIENT DID NOT KNOW WHAT THEIR SETTINGS WERE AFTER THE REPROGRAMMING WITH THEIR HCP. THE PATIENT HAD CALLED THEIR HCP BUT WAS INFORMED THAT THE MANUFACTURER REPRESENTATIVE COULD NOT BE AT AN APPOINTMENT UNTIL AFTER AUGUST. IT WAS NOTED THAT THE PATIENT WOULD CALL THEIR HCP OFFICE TO GET THE SETTINGS FROM THEIR APPOINTMENT AND CALL BACK FOR ASSISTANCE IN PROGRAMMING TO THE SETTINGS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SYMPTOM RETURN SINCE THEIR PROGRAMMING ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A 50 PERCENT OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS DETERMINED AND IT WAS NOT DEVICE RELATED. IT WAS NOTED THAT REPROGRAMMING WAS NOT NEEDED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458233 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1