BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3851569 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10165
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 14, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 399930, LOT# V031530, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WANTED TO USE THE PATIENT PROGRAMMER (PP) BUT SHE SAW THE POOR COMMUNICATION. THIS SCREEN WAS NOTICED A COUPLE MONTHS AGO. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE LAST TIME THE PATIENT CHARGED HER INS WAS 3 WEEKS AGO. THE PATIENT USED A QUARTER OF THE STIMULATION SO SHE DECIDED TO CHARGE AGAIN. THE PATIENT FULLY CHARGED IT AND TODAY THE RECHARGER SHOWED THAT THE INS WAS FULLY CHARGED. AN INFORMATION REQUEST WAS MADE ON THE PP AND CONTROL MAGNET. THE PATIENT WAS ABLE TO PULL UP THE REGULAR PROGRAMMING SCREEN. THE PATIENT WAS ON GROUP A, PROGRAM 1 AT 4.10V. THE STIMULATION WAS ON. WHEN THE PATIENT LAYS DOWN THE STIMULATION WAS TOO STRONG. IT WAS USUALLY TOO HIGH, THIS HAS BEEN AN ISSUE SINCE THE PATIENT WAS FIRST IMPLANTED. THE PATIENT DOES NOT HAVE A FOLLOW UP HEALTH CARE PROVIDER (HCP) ANYMORE. THE PATIENT TRIED DECREASING THE STIMULATION TO 3.30V AND THEN TURNED IT BACK UP TO 4.20V. THE STIMULATION FELT COMFORTABLE THERE AND IN THE RIGHT SPOT. WHEN THE PATIENT LAYS DOWN SHE DOES NOT FEEL THE STIMULATION AND WHEN SHE STANDS UP SHE DOES. STIMULATION GIVES THE PATIENT AN EXTRA FINE JOLT. IT WAS NOTED THAT THE PATIENT DOES NOT HAVE ANYONE THERE TO HELP HER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329111 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR