BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2934493 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01102
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA01NGW, 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 EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A LOSS OF BLADDER CONTROL FOR THE WEEK PRIOR TO THE REPORT. THE PATIENT ALSO EXPERIENCED A BURNING SENSATION WHEN STIMULATION WAS INCREASED. THE SYMPTOMS WERE REPORTED TO HAVE OCCURRED FOLLOWING A FALL, AND IT WAS NOTED THAT THE PATIENT HAD FALLEN SEVERAL TIMES. THE REPORTER STATED THAT THE PATIENT WAS ON THE WAY TO THE HOSPITAL BECAUSE OF A 'POSSIBLE MINI STROKE.' IT WAS INDICATED THAT THE PATIENT WAS 'INCOHERENT.' THE REPORTER ALSO NOTED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH HER HEALTHCARE PROVIDER (HCP) ON (B)(6) 2013. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41024 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1