BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3955226 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13482
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-33, LOT # V394049, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V298142, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT # V394049, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-45, LOT # V298142, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT DOES NOT USE HER STIMULATION VERY MUCH ¿BECAUSE SOMETIMES I JUST FORGET TO TURN IT ON OR CHARGE IT OR WHATEVER, BUT I TRIED CHARGING IT RIGHT NOW BECAUSE IT¿S AT 0, ITS TRYING TO CHARGE AND I TRIED TURNING IT ON AND NOW IT¿S JUST LIKE PULSING IN MY BACK AND I CAN¿T TURN IT OFF.¿ THE PATIENT TRIED TO USE HER PATIENT PROGRAMMER (PP) AND SAW THE SCREEN SAYING TO RECHARGE HER INS BATTERY. FOUR COUPLING BOXES WERE SEEN ON THE RECHARGER SCREEN, ¿THE MOST IT GETS IS (B)(4)BOXES BUT IT IS CHARGING.¿ THERE WAS NO LIGHTNING BOLT SO THAT STATES THE STIMULATION WAS OFF. AN INFORMATION REQUEST WAS MADE REGARDING THE RECHARGER/RECHARGING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434932 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 00041 YR