BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3943654 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13221
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 27, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37092, LOT# 252640002, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATION HAD NOT BEEN WORKING SINCE HIS LAST CHARGE. IT WAS NOTED THAT THE PATIENT WAS GETTING A 3 DIGIT CODE WHEN HE WOULD TRY TO TURN ON HIS STIMULATION. IT WAS NOTED THAT THERE WAS ¿A TRIANGLE WITH AN EXCLAMATION MARK ON IT¿ AND A ¿CIRCLE WITH JAGGED LINES OVER TOWARDS A BATTERY.¿ IT WAS NOTED THAT THE PATIENT HAD LAST CHARGED ON ¿LAST TUESDAY OR WEDNESDAY¿ FOR A TOTAL OF 4-4.5 HOURS. IT WAS NOTED THAT THE WARNING SCREEN HAD FIRST BEEN SEEN ON ¿LAST THURSDAY OR FRIDAY.¿ IT WAS STATED THAT THE WARNING SCREEN HAD APPEARED AFTER THE PATIENT HAD CHARGED THE FIRST TIME. IT WAS STATED THAT ¿AS LONG AS THE ICON BASED THING ARE OKAY AND THE GREYED IN BOX.¿ IT WAS NOTED THAT THE PATIENT ¿FELT BETTER KNOWING WHAT THINGS MEANT.¿ IT WAS NOTED THAT THERE WAS A COMMUNICATION PROBLEM WITH THE RECHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422436 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 00063 YR