BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3080224 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06955
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA06MQX, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SLIPPED DOWN ABOUT 3 FEET ON A LITTLE SLIDE-DOWN TYPE OF THING AND WAS READING WHEN ALL OF THE SUDDEN THE STIMULATION WAS IN THEIR LEG.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE THERAPY BUT WAS WORKING WITH THEIR DOCTOR AND MANUFACTURER¿S REPRESENTATIVE TO RESOLVE THE ISSUE. THE PATIENT HAD AN APPOINTMENTSCHEDULED FOR (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THEY WERE STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR PHYSICIAN OR A MANUFACTURER¿S REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2013 WAS LISTED. IT WAS ALSO NOTED THAT THE PATIENT WAS ¿STILL WORKING WITH THE PROGRAMS.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 3-4 DAYS AGO THE PATIENT WAS WEEDING AND SAT ABOUT 3 FEET DOWN AND NOTICED THAT HER STIMULATION MOVED TO HER LEG AREA VERSUS THE VAGINAL AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182856 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR