BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3735593 · Received April 9, 2014

    Report

    Report Number
    3004209178-2014-05845
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Report Date
    March 20, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3093-33, LOT# V973942, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-33, LOT# V973942, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. THREE APPOINTMENTS IN (B)(6) 2014 WERE NOTED. IT WAS INDICATED THE PATIENT HAD TESTS DONE AND IT APPEARED THEY HAD STRESS INCONTINENCE. THE PATIENT WAS SCHEDULED FOR A ¿CYTO HYPEREXTENSION¿ OF THEIR BLADDER ON (B)(6) 2014. IT WAS STATED THE DEVICE WAS ¿WORKING,¿ BUT NOT CONTROLLING THE URINE OUTPUT. THE PATIENT ¿WENT CONSTANTLY.¿ IT WAS STATED THE PATIENT WAS PRESCRIBED MEDICATION AND IT ¿HELPED.¿ IT WAS UNCLEAR WHICH TYPE OF MEDICATION WAS GIVEN. AN ADDITIONAL FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STARTED HAVING PROBLEMS IN (B)(6) 2013 AS THE ¿SYSTEM WAS NOT WORKING PROPERLY¿ IT WAS STATED THE PATIENT HAD TRIED TO HAVE MULTIPLE APPOINTMENTS, BUT THEY HAD BEEN CANCELLED. THE PATIENT WANTED THE DEVICE REMOVED. IT WAS STATED THE PATIENT WAS NOT DRINKING THE LIQUIDS THEY SHOULD BECAUSE THEY COULD NOT MAKE IT TO THE RESTROOM ON TIME. IT WAS EMBARRASSING FOR THE PATIENT. THE PATIENT WAS LOOKING FOR A MANUFACTURER REPRESENTATIVE TO ASSIST. THE FOLLOWING DAY, IT WAS STATED THAT IT WAS NOT BELIEVED THE IMPLANTABLE NEUROSTIMULATOR WAS WORKING. WHEN THE PATIENT WOULD GET UP AND LEAVE A MEETING, URINE WOULD RUN DOWN THEIR LEG. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213699 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1