BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2942054 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01264
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 14, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V836403, 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 THERE WAS A LOSS OF THERAPEUTIC EFFECT AND A LOSS OF BLADDER CONTROL FOLLOWING A FALL. IT WAS NOTED THE PATIENT FELL BETWEEN (B)(6) WHILE WALKING THEIR DOG AND THE PATIENT 'LANDED ON THEIR BOTTOM.' IT WAS NOTED THERE WAS NO STIMULATION SENSATION AT 3.05. IT WAS NOTED THAT TYPICALLY THIS SETTING WOULD BE VERY STRONG BUT THE PATIENT WAS UNABLE TO FEEL ANY STIMULATION. IT WAS CONFIRMED THAT STIMULATION WAS ON AND THAT PROGRAM FOUR WAS SELECTED. PATIENT INCREASED TO 3.06 AND STILL DID NOT FEEL STIMULATION. IT WAS NOTED THE PATIENT HAD PUT NEW BATTERIES IN THE PATIENT PROGRAMMER. PATIENT SERVICES ATTEMPTED TO HAVE PATIENT CHANGE PROGRAMS TO SEE IF STIMULATION COULD BE FELT ON ANOTHER PROGRAM BUT THE PATIENT 'DID NOT WANT TO MESS WITH IT.' IT WAS NOTED THE PATIENT DID NOT SEE A REPRESENTATIVE AFTER IMPLANT AND WAS NOT SHOWN HOW TO USE THE PATIENT PROGRAMMER. PATIENT HAD BEEN TRYING TO FIGURE IT OUT BY READING THE PATIENT MANUAL. IT WAS NOTED THE PATIENT WOULD CALL THEIR HEALTH CARE PROVIDER TO HAVE THE DEVICE CHECKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46902 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1