BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3653779 · Received February 28, 2014

    Report

    Report Number
    3004209178-2014-03775
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Report Date
    February 12, 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 PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V811041, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S THERAPY HADN¿T BEEN WORKING ¿VERY WELL¿. THE PATIENT HAD ALSO BEEN EXPERIENCING A BURNING SENSATION IN HER ¿BACKSIDE, OPPOSITE THE SIDE OF HER IMPLANT¿. CONSEQUENTLY, THE PATIENT SCHEDULED AN APPOINTMENT FOR SOME DIAGNOSTICS. IMPEDANCE TESTING SHOWED IMPEDANCES WERE GREATER THAN 4,000 OHMS ON ALL BUT 3 CONTACTS. THE BURNING SENSATION REPORTEDLY STARTED THEN AS WELL. THE PATIENT HAD TURNED IT OFF IN THE PAST. HOWEVER, STIMULATION WAS ON AT THE TIME OF THE REPORT AS THE PATIENT WAS INSTRUCTED NOT TO ¿MESS WITH IT¿. THERE HAD BEEN NO FALLS OR TRAUMA RELATED TO THIS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123602 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1