BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3496621 · Received December 3, 2013

    Report

    Report Number
    3004209178-2013-21778
    Event Type
    Malfunction
    Date Received
    December 3, 2013
    Report Date
    November 18, 2013
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3998, LOT# V163064, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS NOTED THAT THERE WAS A CALL YOUR DOCTOR ICON ALONG WITH A 006 CODE. IT WAS NOTED THAT THE PATIENT KEPT SEEING THE SPLASH SCREEN ON THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT HAD AN OVERSTIMULATION SENSATION. IT WAS NOTED THAT THE STIMULATION WAS UP ¿FULL BLAST¿ AND THE PATIENT COULD NOT TURN IT OFF. IT WAS NOTED THAT THE STIMULATION FELT LIKE ¿THE PATIENT WAS STICKING THEIR FINGER IN A LIGHT SOCKET TIMES TWO.¿ IT WAS NOTED THAT THE PATIENT WAS NOT SURE HOW THE STIMULATION GOT TURNED UP SO HIGH; IT WAS NOTED THAT THE PATIENT WAS AT A PHARMACY AND THE PROGRAMMER WAS IN THE PATIENT¿S PURSE. IT WAS NOTED THAT THE PATIENT WAS NOT ABLE TO CONNECT WITH THE PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR HEALTHCARE PROFESSIONAL (HCP) OR MANUFACTURING REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625973 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 00051 YR