BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3913305 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12517
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT # N322354, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS), THE PATIENT SAW A POWER ON RESET (POR) MESSAGE ON THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR). IT WAS STATED THAT THE DISPLAY WAS SHOWING A ¿CALL YOUR DOCTOR¿ ICON. IT WAS STATED THAT THE POR MESSAGE WAS FIRST SEEN ON THE DAY OF THIS REPORT. IT WAS STATED THAT THE PATIENT WAS ABLE TO CLEAR THE POR MESSAGE AND CHARGE THE INS. IT WAS NOTED THAT THE PATIENT¿S STIMULATION WAS OFF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEING THE ¿REPOSITION ANTENNA¿ SCREEN. IT WAS STATED THAT THE PATIENT WAS UNABLE TO ADJUST THE STIMULATION. IT WAS NOTED THAT THE DISPLAY WAS SHOWING A ¿CALL YOUR DOCTOR¿ ICON. IT WAS STATED THAT THERE WAS A POR CONDITION. IT WAS STATED THAT THE PATIENT HAD PREVIOUSLY BEEN INSTRUCTED ON HOW TO CLEAR THE POR. IT WAS STATED THAT THE PATIENT WAS ¿ABLE TO SYNCHRONIZE AS NORMAL,¿ BUT WAS NOT ABLE TO FEEL ANY STIMULATION. IT WAS NOTED THAT ¿IT CHARGED FOR LIKE A MINUTE,¿ BUT THEN WOULDN¿T CHARGE. IT WAS STATED THAT THE INS HAD BEEN TURNING ON AND OFF. IT WAS NOTED THAT THE STIMULATION WAS SET TO 3.5 AND ¿THE JUICE WAS CRANKED ALL THE WAY UP,¿ BUT THE PATIENT WASN¿T ¿FEELING ANYTHING.¿ IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390253 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 00029 YR