BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 5118275 · Received October 1, 2015

    Report

    Report Number
    3004209178-2015-19187
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Report Date
    August 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 MEDICAL PRODUCTS: PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE THERAPY WAS TURNING OFF BY ITSELF. THE CONSUMER FELT LIKE THIS BEGAN AFTER THEY WERE PROGRAMMED WITH HIGH DENSITY SETTINGS. THESE SETTINGS WERE PROGRAMMED FIVE WEEKS PRIOR TO THE REPORT AND THE TURNING OFF OCCURRED FOR THREE WEEKS PRIOR TO THE REPORT. THE CONSUMER WAS PROGRAMMED WITH A RATE OF 1000HZ AND A PULSE WIDTH OF 150 MICRO-SECONDS. THERE WERE NO ERROR CODES REPORTED. THE STIMULATION ON/OFF WAS NOT RELATED TO POSITIONAL MOVEMENT. DURING THE EVENT THE CONSUMER WAS ABLE TO CONFIRM THE IMPLANTABLE NEUROSTIMULATOR STATUS WITH THE PATIENT PROGRAMMER CORRECTLY. WHEN STIMULATION FELT AS THOUGH IT WAS OFF, UPON CHECKING WITH THE PATIENT PROGRAMMER, IT WAS CONFIRMED THAT IT WAS OFF. THE ELECTRODE IMPEDANCES WERE IN THE RANGE OF 586-1668 OHMS. RECHARGING STATISTICS WERE PROVIDED AS FOLLOWS: 8/2 DURATION 0.5 HOURS PERCENT AT END OF CHARGE 75%; 7/31 DURATION 2.0 HOURS PERCENT AT END OF CHARGE 75%; 7/28 DURATION 1.4 HOURS PERCENT AT END OF CHARGE 75%; 7/28 DURATION 1.1 HOURS PERCENT AT END OF CHARGE 75%; 7/27 DURATION 0.8 HOURS PERCENT AT END OF CHARGE 75%; 7/27 DURATION 1.2 HOURS PERCENT AT END OF CHARGE 100%. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE BATTERY HAD BEEN INTERROGATED AND NO ISSUES HAD BEEN FOUND. THE PATIENT WAS INSTRUCTED TO KEEP A DETAILED LOG AND TO FOLLOW-UP IF THE ISSUE CONTINUED. SHE WAS NO LONGER USING HIGH DENSITY PROGRAMMING DUE TO THE CHARGING FREQUENCY. THE PATIENT HAD NOT BEEN HEARD FROM SINCE. THE INDICATION FOR USE WAS SPINAL PAIN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE EVENT WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651752 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1