BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5014135 · Received August 19, 2015

    Report

    Report Number
    3004209178-2015-16273
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Report Date
    July 24, 2015
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4)IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-39, LOT# N200282, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT, IMPLANTED FOR LUMBAR RADICULOPATHY, THEIR DEVICE WAS FULLY CHARGED BUT NOT WORKING. THEY COULD NOT FEEL STIMULATION. THEY HAD TRIED TO USE THEIR PATIENT PROGRAMMER TO INCREASE STIMULATION BUT STILL COULD NOT FEEL IT. THE PATIENT TRIED TO SYNC USING THE PATIENT PROGRAMMER BUT HAD POOR COMMUNICATION. THEY TRIED SYNCING AGAIN WITH THE PATIENT PROGRAMMER, THIS TIME WITHOUT THE ANTENNA, AND WERE ABLE TO SYNC AND SAW 1.8V. THEY PLUGGED IN THE ANTENNA AGAIN AND THIS TIME IT SHOWED THE INS ICON WAS EMPTY. THEY REVIEWED ICONS OVER THE PHONE AND THE PATIENT PRESSED THE STIM ON BUTTON AND THEN SAW THE LIGHTNING BOLT INDICATING THE STIMULATION WAS ON AND THEY WERE ABLE TO FEEL STIMULATION. THE PATIENT HAD BEEN TRYING THAT ALL DAY THE DAY PRIOR AND IT WOULD NOT TURN ON. THE PATIENT TYPICALLY CHARGES EVERY WEEK BUT THIS TIME THEY WAITED TWO WEEKS BUT WERE STILL ABLE TO CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) AND FULLY CHARGE THE BATTERY. THEY HAD NO FALLS OR TRAUMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550178 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 00065 YR