BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4122634 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17821
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 4, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V689338, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED NOT BEING ABLE TO ADJUST STIMULATION. THE PATIENT HAD BEEN TRYING TO ADJUST STIM AND PP SHOWED HER 'UPPER LIMIT REACHED' SCREEN. PATIENT WAS NOT ABLE TO GO HIGHER THAN 2.9 V, BUT SHE USED TO BE ABLE TO INCREASE HIGHER THAN THAT. THE PATIENT GOT THE SCREEN ON THE DAY OF THE CALL AND A COUPLE OF WEEKS AGO WHEN SHE TRIED USING PROGRAMMER (PP). THE PATIENT SCREEN WAS ALSO SHOWING 'TURN YOUR INS ON¿ SCREEN. THE PATIENT¿S THERAPY WAS TURNED OFF AND THEREFORE, SHE WAS NOT ABLE TO INCREASE STIMULATION AND PATIENT WAS ASSISTED TO TURN STIMULATION BACK ON. THE PATIENT DID NOT REALIZE HER THERAPY WAS TURNED OFF. IT WAS NOTED THAT PATIENT DID NOT SEEM TO UNDERSTAND HOW TO USE PP WELL. THE PATIENT ASKED IF SHE NEEDED TO PUSH THE MIDDLE BUTTON TO SYNC. ON THE CALL, PATIENT WAS ABLE TO SUCCESSFULLY CONNECT AND TURN ON THE THERAPY. THE PATIENT WAS AT 1 V IN P 3. THE PATIENT INCREASED HER STIM AND CONFIRMED SHE FELT STIM NOW. THE PATIENT STATED SHE PROBABLY SOMEHOW TURNED HER STIM OFF. SHE STOPPED FEELING STIM AND HAD SYMPTOMS RETURNED A FEW WEEKS. THE PATIENT STATED SHE HAD A UTI INFECTION A MONTH AGO AND IT WAS HARD TO TELL IF THERAPY WAS WORKING OR NOT. THE PATIENT ALSO INDICATED THAT SHE HAD A CHRONIC THING FOR GETTING UTI INFECTIONS. IT WAS LATER REPORTED SIX DAYS LATER THAT THE PATIENT WAS GETTING 50% OF SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS NOTED THAT IT WAS NOT DEVICE RELATED AND PATIENT DID NOT NEED TO BE REPROGRAMMED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602081 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Required Intervention