BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4261672 · Received November 19, 2014

    Report

    Report Number
    3004209178-2014-21856
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Report Date
    November 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 377645, LOT# V009913, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 377645, LOT# V013538, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD, PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CONFIRMED OVER-DISCHARGE. THE PATIENT HAD BEEN SEEING AN ERROR MESSAGE ON THEIR IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) FOR APPROXIMATELY 2 MONTHS AND THEY HAD BEEN UNABLE TO USE THEIR STIMULATION FOR THREE MONTHS. THE LAST SUCCESSFUL RECHARGE WAS APPROXIMATELY 3-4 MONTHS PRIOR TO THE REPORT. IT WAS NOTED THE PATIENT TYPICALLY CHARGED EVERY 2-3 WEEKS. STIMULATION SENSATION STOPPED TWO MONTHS PRIOR. THE ANTENNA LOCATE FEATURE WAS ATTEMPTED 4 TIMES. IT WAS NOTED THE PATIENT WAS UNABLE TO TURN STIMULATION ON. THE PATIENT FURTHER NOTED THEY WERE GETTING LESS THAN 50% THERAPY RELIEF AND HAD INCREASED PAIN FROM AN INCIDENT OVER THE SUMMER SO THEY WANTED TO TURN THEIR STIMULATION BACK ON TO HELP WITH THEIR CHRONIC LEG PAIN. ON (B)(6) 2014 ANOTHER ANTENNA LOCATE WAS PERFORMED WITH A NEW CHARGER TO CONFIRM THE PROPER ANTENNA LOCATION. WHILE USING THE NEW RECHARGER COMMUNICATION WAS NOT POSSIBLE. SINCE THE ORIGINAL REPORT IN (B)(6) 2013, THE PATIENT HAD STILL NOT CHARGED THEIR DEVICE BECAUSE THEY WERE DOING ALRIGHT WITHOUT IT. ON (B)(6) 2014 A PHYSICIAN MODE RESET (PMR) WAS PERFORMED AND THE 0X2608 POWER ON RESET (POR) MESSAGE WAS SUCCESSFULLY CLEARED. THE PATIENT WAS ABLE TO CHARGE THEIR DEVICE FULLY WITH FULL COUPLING BARS AND WAS TO MEET WITH THEIR MANUFACTURER REPRESENTATIVE ON (B)(6) 2014 FOR REPROGRAMMING. WHEN THEY MET WITH THEIR MANUFACTURER REPRESENTATIVE IN (B)(6) 2014 AND THE DEVICE WAS REPROGRAMMED. THE REPROGRAMMING OPTIMIZED THE COVERAGE AND THE PATIENT WAS NOTED TO BE DOING WELL AND WAS PLEASED TO HAVE THEIR STIMULATION BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750050 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR