BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4166994 · Received October 13, 2014

    Report

    Report Number
    3004209178-2014-19550
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Report Date
    September 22, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V896800, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. THE PATIENT GOT A NEW KNEE AND MUST RIDE A STATIONARY BIKE AND 2 OR 3 DAYS AGO WHEN THEY WERE RIDING THIS BIKE THEY FELT ALL AT ONCE PAIN IN THEIR BOTTOM OR CRACK. IT FELT LIKE THE STIMULATION CHANGED LOCATIONS AND THEY PATIENT FELT LIKE THEY HAD TO GET UP LIKE THEY COULDN¿T SIT ANYMORE. AFTER THE INCIDENT THE PATIENT STARTED MESSING WITH THE PATIENT PROGRAMMER REMOTE AND THOUGHT THEY ACCIDENTALLY SWITCHED PROGRAMS. THE PATIENT WAS USUALLY ON PROGRAM 4 AND THE PROGRAMMER SHOWED THAT THE PATIENT WAS ON PROGRAM 4 AT 0.4V AND LATER SAID THAT THE INITIAL SETTING WAS 1.2V. THE PATIENT CHANGED TO PROGRAM 2 AT 1.2V AND TURNED STIMULATION ON AND THEY DID NOT FEEL STIMULATION. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY AND RECEIVED ASSISTANCE FROM THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT HAD AN APPOINTMENT WITH THEIR NURSE ON (B)(6) 2014 BY TELEPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647823 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1