BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3926456 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12797
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL #(B)(4) , PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(4) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THE PATIENT WAS SEEING A CALL YOU DOCTOR ICON WITH A POWER ON RESET (POR) CONDITION. IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) IS CHARGED BUT EVERY ONCE IN A WHILE IT SHUTS OFF AND THE INFORMATIONAL POR APPEARS. IT WAS NOTED THE PATIENT JUST STARTED RADIATION IN THEIR CHEST FOR LUNG CANCER BUT THEIR INS IS IN THEIR HIP. IT WAS NOTED THE POR SHOWED ONE OR TWO TIMES PRIOR TO STARTING RADIATION. IT WAS REPORTED THAT DURING ONE TREATMENT A PROBE WAS PUT OVER THE INS TO DETERMINE HOW MUCH RADIATION IT WAS GETTING AND IT SHOWED NONE. IT WAS NOTED THE PATIENT WAS ABLE TO CLEAR THE POR BY PRESSING A BUTTON. THE PATIENT REPORTED THEY HAD NOT BEEN AROUND ANY STRONG EMI AND REPORTED THE POR HAPPENED DURING THE NIGHT. IT WAS FURTHER REPORTED THE PATIENT¿S FIRST POWER ON RESET (POR) CONDITION OCCURRED 3 WEEKS PRIOR TO REPORT FOLLOWING EMI EXPOSURE. IT WAS NOTED THE PATIENT WAS ABLE TO CLEAR THE FIRST 3 OR 4 PORS WITH THEIR PATIENT PROGRAMMER BUT HAD TO MEET WITH THEIR MANUFACTURER REPRESENTATIVE TO CLEAR A WARNING POR, 0X400. IT WAS NOTED THE FIRST EMI OCCURRED ONE WEEK AFTER HAVING MULTIPLE CT SCANS PERFORMED. IT WAS NOTED THE PATIENT HAS BEEN HAVING RADIATION TREATMENTS THE LAST 10 DAYS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS EXPERIENCING INCREASED PAIN DUE TO THE DEVICE BEING OFF. IT WAS REPORTED THE DEVICE HAD SEVERAL POWER ON RESETS (POR) DUE TO RADIATION THERAPY THE PATIENT HAD BEEN RECEIVING AND THE MANUFACTURER REPRESENTATIVE WAS ABLE TO CLEAR THE POR WITH THEIR CLINICIAN PROGRAMMER. IT WAS NOTED THE PATIENT WAS NOW DOING FINE AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404119 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 00052 YR