BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3910199 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12453
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # VA0AZ0P, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AT THE AIRPORT AND THEY MADE THEM GO THROUGH THE SECURITY GATE. THE PATIENT DID NOT TURN STIMULATION OFF BEFORE GOING THROUGH THE SECURITY GATE. IT WAS NOTED THAT THE PATIENT DID NOT FEEL AN INCREASE IN STIMULATION WHEN PASSING THROUGH THE SECURITY GATE AND THEY PASSED THROUGH IT TODAY SHORTLY BEFORE CALLING IN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT SURE IF THERE WERE ANY SYMPTOMS. THE PATIENT¿S SON WHO IS A HEALTH CARE PROVIDER (HCP) HAD SOME ADDITIONAL QUESTIONS. IT WAS NOTED THAT IN THE PREVIOUS CALL THE PATIENT WAS ASKED IF THEY FELT OVERSTIMULATION AND THEY DIDN¿T KNOW IF THEY DID OR DIDN¿T BECAUSE THEY FELT SOMETHING. THE PATIENT WANTED TO KNOW IF IT RUINED THE DEVICE AND WOULD HAVE TO GET IT TAKEN OUT AND REPLACED. IT WAS REPORTED THAT THE PATIENT HAD NOT CHECKED THE STATUS OF THEIR STIMULATION WITH THE PATIENT PROGRAMMER YET AND HAD THE PROGRAMMER IN THEIR SUITCASE AND COULD GO IN THE BATHROOM AND SEE. THE PATIENT SHOULDN¿T HAVE ALLOWED IT TO HAPPEN AND IT TOOK THEM BY SURPRISE AND THE PATIENT HAD THEIR IDENTIFICATION CARD AND SAID THEY DIDN¿T NEED TO GO THROUGH THERE. IT WAS NOTED THAT THE PATIENT WAS ASKED BY TRANSPORTATION SECURITY ADMINISTRATION (TSA)WHERE THEIR DEVICE WAS AND THEY TOLD THEM TO GO THROUGH AND THEY WOULD BE PATTED DOWN AND THE PATIENT WENT AHEAD AND WALKED THROUGH WITHOUT EVEN REALIZING THEY WALKED THROUGH THE METAL DETECTOR GATE. THE TSA AGENT TOLD THE PATIENT THAT THEY DIDN¿T GET THEIR MONEY¿S WORTH BECAUSE THEY DIDN¿T EVEN SET OFF THE ALARM ON THE DETECTOR AND WOULD HAVE HAD THEIR IMPLANT HAD METAL AND THEY DIDN¿T REALIZE THEY WENT THROUGH THE METAL DETECTOR GATE. IT WAS REPORTED THAT THE PATIENT HAD AN ACCIDENT AFTER ARRIVING WHICH WASN¿T UNCOMMON AND THE PATIENT HAD MULTIPLE SCLEROSIS (MS) AND HAD HAD THIS OCCUR BEFORE SO THEY WEREN¿T SURE IF IT WAS RELATED OR NOT. EVEN THE PATIENT¿S HIP FELT A LITTLE UNCOMFORTABLE AND IT WASN¿T PAINFUL EITHER AND THE PATIENT WAS AWARE OF SOMETHING BUT DIDN¿T KNOW WHAT. IT WAS STATED THAT THE PATIENT WOULD CHECK THE STATUS OF THEIR STIMULATION WITH THEIR PROGRAMMER AFTER THEY GOT OFF THE CALL AND WOULD ALSO CALL TSA TO REVIEW WHAT OCCURRED AT THE AIRPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. AFTER DETERMINING THAT THE DEVICE WAS OK AFTER THE X-RAY OR SCAN THE PATIENT WAS OK. IT WAS NOTED THAT THE PATIENT JUST CALLED TO FIND OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386507 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1