BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3971177 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13764
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID N EU_PTM_PROG, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PROGRAMMER WOULD NOT PERFORM TELEMETRY WITH OR WITHOUT THE ANTENNA ATTACHED BUT THE RECHARGER WORKS. IT WAS REPORTED THE PATIENT PROGRAMMER WAS NOT WORKING. IT WAS REPORTED THE PATIENT WAS SEEING THE POOR COMMUNICATION SCREEN WITH OR WITHOUT THE ANTENNA ATTACHED. IT WAS NOTED THE PROBLEM BEGAN APPROXIMATELY 3 DAYS PRIOR TO REPORT AND IT WAS NOTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS WORKING JUST FINE. IT WAS REPORTED THE PATIENT TRIED USING ANOTHER PATIENT PROGRAMMER AND IT WORK JUST FINE. LASTLY, IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHARGED. IT WAS FURTHER REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND THE PATIENT PROGRAMMER WAS DISPLAYING THE ¿IN THE BOX¿ ICON. IT WAS NOTED THAT THIS IS SECOND PATIENT PROGRAMMER THE PATIENT HAS BEEN SENT AND THE SAME ISSUES ARE OCCURRING AS WITH THE OLD ONE. IT WAS NOTED THE PATIENT WAS ABLE TO TURN THEIR IMPLANT ON/OFF WITH THEIR RECHARGER. IT WAS REPORTED THE PATIENT IS SEEING ¿HAD HOLDING THE DEVICE WHICH LOOKS LIKE IMAGE OF PROGRAMMER AND THEN THERE IS A LINE FROM RIGHT CORNER THAT GOES TO ANOTHER IMAGE DEVICE¿ ON THE SCREEN. IT WAS NOTED THE PROBLEM HAS BEEN OCCURRING SINCE AROUND (B)(6) 2014. IT WAS REPORTED THE ANTENNA JACK WAS RE-SOLDERED AS A PREVENTATIVE MEASURE AND THE FACEPLATE WAS REPLACED DUE TO SCRATCHES.

    Description of Event or Problem · 1

    LATER, THE PATIENT CALLED ON (B)(6) 2014 AND STATED, ¿WHEN I SAW A REPRESENTATIVE FIVE TO SIX WEEKS BECAUSE SOMETHING STRANGE WAS COMING UP ON THE PROGRAMMER. AND THEY FIXED IT AFTER PUSHING A FEW BUTTONS AND EVERYTHING WAS FINE.¿ THE PATIENT DID NOT REMEMBER WHAT SCREEN SHE OBSERVED ON THE PATIENT PROGRAMMER BUT THE ISSUE WAS NOT HAPPENING ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448581 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 00079 YR