BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3811413 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08988
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-29, LOT # N153073, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POWER ON RESET (POR) CONDITION. IT WAS NOTED THAT THERE WAS A ¿CALL YOUR DOCTOR¿ ICON. IT WAS NOTED THAT THE PATIENT KEPT TRYING TO CHARGE HER IMPLANTABLE NEUROSTIMULATOR (INS) BUT KEPT GETTING A ¿POS¿ MESSAGE ON THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR). IT WAS NOTED THAT THE PATIENT HAD TO MOVE TO AN OUTLET. IT WAS NOTED THAT THE PATIENT THOUGHT THAT THE INSR WAS CHARGED BECAUSE SHE HAD IT ON ALL NIGHT BUT IT WAS NOT. IT WAS NOTED THAT THE PATIENT WAS SEEING A POR MESSAGE. IT WAS NOTED THAT THE PATIENT WOULD NEED TO FOLLOW UP WITH HEALTHCARE PROFESSIONAL (HCP) TO HAVE A WARNING POR MESSAGE CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290009 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 00040 YR