BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3973955 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13861
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 9, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3889-33, LOT# V508731, IMPLANTED: 2010-(B)(6), 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

    IT WAS REPORTED THE THAT THE PATIENT CALLED IN BECAUSE SHE WAS HAVING TERRIBLE PAIN IN HER LEFT HIP AND DIDN'T THINK THE DEVICE WAS WORKING. THE PATIENT SAID SHE WAS HAVING TERRIBLE PAIN IN HER LEFT HIP. THE PATIENT PAIN STARTED ABOUT A MONTH AGO. THE PATIENT SAID SHE FELL AND THE PAIN STARTED SOON AFTER THE FALL. THE PATIENT SAID SHE WAS NOT SURE IF THE DEVICE WAS CAUSING THE HIP PAIN OR IF IT WAS HER BACK PAIN. THE PATIENT MENTIONED SHE DIDN'T THINK THE DEVICE WAS WORKING. THE PATIENT SAID SHE WAS STILL HAVING TROUBLE WITH HER BLADDER AND HAS FOR A LONG TIME. THE PATIENT SAID THE DEVICE DIDN'T HELP MUCH. THE PATIENT REPORTED BEING ON PROGRAM 3. THE PATIENT REPORTED SEEING THE STIMULATION OFF ICON. THE PATIENT PRESS THE STIMULATION ON BUTTON AND SHE REPORTED SEEING THE MESSAGE THE AAA BATTERIES IN THE PATIENT PROGRAMMER NEED TO BE REPLACE. THE PATIENT DIDN'T HAVE BATTERIES AVAILABLE DURING THE CALL. THE PATIENT SAID A YEAR OR TWO AGO SHE DIDN'T THINK HER DEVICE WAS WORKING SO SHE MET A REP AT THE HCP'S (HEALTHCARE PROVIDER) OFFICE. THE PATIENT SAID THE REPRESENTATIVE CHECKED THE DEVICE AND SAID IT WAS OK.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS GOING TO BE USING THE TENS UNIT FOR LOW BACK PAIN. THE PATIENT CALLED IN TO SEE IF SHE CAN USE A TENS UNIT. PATIENT SERVICES ASKED THE PATIENT IF SHE HAD LOW BACK PAIN BEFORE THE IMPLANT. THE PATIENT NOTED SHE HAS HAD LOW BACK PAIN FOR "LIKE 20 YEARS" BUT IT WAS GETTING WORSE NOW. THE PATIENT WAS HAVING A HARD TIME WALKING AND HAD A HERNIATED DISC IN HER BACK. THE PATIENT DIDN'T THINK THE INTERSTIM DEVICE WAS WORKING - THIS STARTED ABOUT A MONTH AGO. THE PATIENT DIDN'T FEEL ANY STIM. THE PATIENT DIDN'T KNOW IF THE DEVICE BROKE OR MOVED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450840 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR