BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5486954 · Received March 8, 2016

    Report

    Report Number
    3004209178-2016-04152
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Report Date
    April 14, 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 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 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT # V181340, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT # V181340, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37761, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID 37761, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER. (B)(6).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS NOT CHARGING. THE CONNECTOR PIN APPEARED CRACKED. THE PATIENT SPOKE TO A MANUFACTURER REPRESENTATIVE (REP) THE DAY OF THE REPORT WHO TOLD THEM TO ASK FOR A NEW DESKTOP CHARGER. THE PATIENT WAS NOT FEELING STIMULATION SO SUSPECTED THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS EMPTY. THE PATIENT WAS NOT ABLE TO CHARGE THE INS BATTERY BECAUSE THEY WERE NOT ABLE TO CHARGE THE INSR BATTERY. IT WAS LATER REPORTED THAT THE PATIENT COULD RECHARGE NORMALLY AND WAS RECEIVING EFFECTIVE THERAPY. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE INDICATION FOR THERAPY WAS RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYNDROME. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143720 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 00080 YR