BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3193181 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10970
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 19, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA02GNW, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD NOTICED A RETURN OF THEIR SYMPTOMS (LOSS OF THERAPEUTIC EFFECT) AT WHICH TIME THEY WENT TO THEIR PHYSICIAN WHERE THEY WERE TOLD TO TURN DOWN THE IMPLANTABLE NEUROSTIMULATOR (INS) FROM 3.9 TO 1.2. THE PATIENT DID NOT FEEL THE STIMULATION AND THAT THE DEVICE WAS NOT CONTROLLING THEIR SYMPTOMS. THE PATIENT WAS ON PROGRAM 1 AT 2.5 WHERE THEY STATED FELT THE STIMULATION AS STRONG AND COMFORTABLE. THE PATIENT WAS GOING TO TRACK THEIR SYMPTOMS TO SEE IT THE THERAPY IS WORKING. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT NOTED AS A LOSS OF BLADDER CONTROL. THERE WAS NO ACCIDENT, TRAUMA, OR INCIDENT REPORTED THAT WAS RELATED TO THE EVENT. IT WAS ALSO REPORTED THAT THE PATIENT ¿HAD SEVERAL BLADDER INFECTIONS¿ IN WHICH THEY TOOK 2 MEDICATIONS FOR THE URINARY TRACT INFECTION BUT NOTED THAT THEY DID NOT CURRENTLY HAVE AN INFECTION. THE PATIENT WAS ON ¿5.0¿ BUT ¿GET LITTLE STIMULATION¿. THE PATIENT REPORTED THAT THEY ¿SEEM TO BE VOIDING THE SAME AMOUNT AS I DID BEFORE THE SURGERY AND USING THE SAME AMOUNT OF PROTECTION¿. IT WAS NOTED THAT SYMPTOMS OF FREQUENCY CAME BACK PRIOR TO THE PATIENT NOT FEELING THE STIMULATION. THE PATIENT FIRST STATED THAT THE SURGERY WAS NOT SUCCESSFULLY BUT THEN REPORTED THAT, INITIALLY, THE INS THERAPY HELPED ¿SLIGHTLY¿ (50%) AND NOTED THAT THE INS WAS SUCCESSFUL. THE PATIENT COULD NOT RECALL THE SETTING THEY WERE ON WHEN THE DEVICE THERAPY WAS HELPING AND NOTED THAT THE LAST TIME THE PATIENT SAW THEIR PHYSICIAN WAS SEVERAL MONTHS AGO. IT WAS ALSO REPORTED THAT THE PATIENT PUT NEW BATTERIES INTO THE PROGRAMMER UNIT AND THEN COULD NOT GET ANY LIGHTS OR SOUND. IT WAS LATER NOTED THAT THE PATIENT HAD USED LITHIUM INSTEAD OF ALKALINE BATTERIES. IT WAS VERIFIED THAT THE PROGRAMMER WAS WORKING AS INTENDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293845 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention