BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5919173 · Received August 31, 2016

    Report

    Report Number
    3004209178-2016-18031
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    January 1, 2014
    Report Date
    August 31, 2016
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE AND A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THEY WERE FIRST IMPLANTED IN 1997 AND THEN HAD A BATTERY CHANGE IN 2012. THIS NEW ONE STOPPED WORKING COMPLETELY. THE PATIENT DID NOT LIKE THE NEW STYLE BECAUSE YOU HAD TO CHARGER EVERY 1 WEEK TO 1.5 WEEKS. IT COULD TAKE 5 HOURS TO CHARGE. THE PATIENT STATED THAT THEY NEVER HAD THIS ISSUE WITH THE OLD STYLE. THE OLD STYLE OF THEIR FIRST DEVICE HAD A PERMANENT BATTERY AND THE PATIENT REALLY LIKE IT. THE PATIENT REPORTED THAT THEY CHARGED TOO OFTEN. IT WAS ORIGINALLY REPORTED THAT THE PATIENT CHARGED EVERY 2 WEEKS IN THE FIRST YEAR AFTER IMPLANT, BUT THAT HAD CHANGED AND THEY NOW HAD TO CHARGE EVERY 5 DAYS. THE PATIENT STATED THAT AFTER THE FIRST YEAR THE RECHARGING BURDEN HAD BECOME A PROBLEM. THE PATIENT WAS STARTING TO CHARGE AT 25% CHARGE LEVEL OR LESS. THE PATIENT HAD NOT BEEN REPROGRAMMED AND DID NOT INCREASE OR CHANGE THEIR SETTINGS. IMPEDANCES WERE RUN. THE PATIENT USED GROUP A WITH SETTINGS OF 2 BEING THE CATHODE, 1 BEING THE ANODE, 2.5V, 450 MICROSECONDS, 35 HERTZ, 14 HRS/PER DAY= 38 DAYS, AND THE GROUP IMPEDANCES WERE 394OHMS WITH ALL ELECTRODES WITHIN NORMAL RANGE. IT WAS REPORTED THAT THE PATIENT HAD BEEN USING STIMULATION RECENTLY; HOWEVER, THEIR LAST RECHARGE SESSION WAS REPORTED TO HAVE BEEN IN (B)(6) 2016. THE RECHARGE STATISTICS FROM THE CLINICIAN PROGRAMMER WERE 2000-03-01 0.5 HOURS WITH 100%, 2000-03-01 HOURS WITH 100% CHARGE, 2000-03-01 4.7 HOURS WITH 100%, 2015-12-15 FOR 2.3 HOURS WITH 50% CHARGE, 2016-01-292.5 HOURS WITH 50% CHARGE, AND 2016-03-08 2.2 HOURS WITH 75% CHARGE. THE TYPICAL COUPLING WAS ALL 8 BARS. THE PATIENT HAD A PERSISTENT THERMOMETER ICON. THE PATIENT FELT WARMTH WITH RECHARGING SOMETIMES AND IT FELT LIKE BURNING SO THEY WOULD STOP CHARGING. THE PATIENT DID NOT GET THIS HEATING, BURNING, THERMOMETER ICON WITH EVERY RECHARGE SESSION. IT ONLY HAPPENED WITH SOME RECHARGE SESSIONS. THE HEATING DURING RECHARGE WAS AT THE INS POCKET. THE PATIENT WAS CHARGING THROUGH THEIR T-SHIRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568599 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 60 YR