BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3671067 · Received March 10, 2014

    Report

    Report Number
    3004209178-2014-04187
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Report Date
    February 17, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-45, LOT # V390371, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-33, LOT # V383867, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # V181339, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # V188124, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT MET WITH THE MANUFACTURING REPRESENTATIVE FOR REGULAR REPROGRAMMING AND THE ¿LEFT SIDE OF HER BACK WASN¿T COVERING AS WELL AS IT HAD BEEN.¿ IT WAS NOTED THAT IMPEDANCE TESTING WAS PERFORMED AND REVEALED THAT 7 AND 13 WERE GREATER THAN 10,000 OHMS. IT WAS NOTED THAT 7 WAS ACTIVE IN ONE OF THE PROGRAMS, SO THE MANUFACTURING REPRESENTATIVE REMOVED IT AND THE PATIENT WAS HAPPY WITH THE COVERAGE. IT WAS NOTED THAT THE PATIENT WAS DOING FINE AT THE TIME OF THE REPORT AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142877 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