BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4101651 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17359
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 25, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3998, LOT# V020688, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD LOSS OF THERAPEUTIC EFFECT AND A RETURN OF PAIN SYMPTOMS. IT WAS STATED THAT THE PATIENT HAD AN APPOINTMENT WITH HIS HEALTHCARE PROFESSIONAL (HCP) WEDNESDAY AND WANTED A MANUFACTURER¿S REPRESENTATIVE PRESENT TO MAKE AN ADJUSTMENT TO HIS STIMULATOR. IT WAS STATED THAT THE STIMULATOR WAS ¿ACTING UP.¿ IT WAS STATED THAT THE BURNING PAIN IN THE PATIENT¿S LEG HAD RETURNED STARTING LAST WEDNESDAY. IT WAS NOTED THAT THE PATIENT HAD NO FALLS OR TRAUMA. IT WAS STATED THAT THE PAIN CAME BACK SUDDENLY WHEN THE PATIENT GOT UP AT NIGHT FOR A GLASS OF WATER. IT WAS STATED THAT THE PATIENT HAD TO GET BACK IN BED BECAUSE OF THE BURNING PAIN AND THE PATIENT WAS NOT ABLE TO PUT PRESSURE ON HIS LEG. IT WAS STATED THAT THE PATIENT WAS FEELING STIMULATION, HE HAS TRIED TO MAKE ADJUSTMENTS AND IT DID NOT HELP. IT WAS STATED THAT THE STIMULATION WAS NOT HITTING THE RIGHT SPOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584006 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR