BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2833300 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10290
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39, LOT# N316695, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OVERSTIMULATION SENSATION WHICH BEGAN "ABOUT 2 HOURS" PRIOR TO THE REPORT. IT WAS STATED THAT THE PATIENT PROGRAMMER AND CLINICIAN PROGRAMMER WERE UNABLE TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) TO TURN THE DEVICE ON OR OFF. IT WAS NOTED THAT CLINICIAN PROGRAMMER DISPLAYED "DEVICE IS DISCHARGED, CHARGE NOW" MESSAGE. THE PATIENT REPORTEDLY USED THE RECHARGER AND WAS ABLE TO "SUCCESSFULLY" START A CHARGING SESSION. IT WAS STATED THAT THE INS ICON ON THE RECHARGER INDICATED THAT THE INS WAS OFF EVEN THOUGH THEN PATIENT WAS EXPERIENCING "UNCOMFORTABLE" STIMULATION. THE SCREEN REPORTEDLY CHANGED FROM CHARGING SCREEN TO "POOR COMMUNICATION/REPOSITION THE ANTENNA AND TRY AGAIN" SCREEN WHEN THE "STIMULATION ON BUTTON WAS ATTEMPTED." IT WAS NOTED THAT THIS WAS ATTEMPTED TWICE AND HAD THE SAME RESULT. IT WAS STATED THAT A PHYSICIAN MODE RECHARGE (PMR) WAS ATTEMPTED AND "SUCCESSFULLY" TURNED THE STIMULATION OFF. IT WAS NOTED THAT THE PATIENT WAS THEN ABLE TO CONTINUE SUCCESSFULLY CHARGING THE DEVICE FOLLOWING THE PMR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE WAS NOT DETERMINED HOWEVER THE ISSUE HAD NOT SINCE OCCURRED. IT WAS NOTED ACTIVE STIMULATION HAD BEEN MAINTAINED AND THE PATIENT WAS RECEIVING GOOD STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00050 YR