BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4213895 · Received October 30, 2014

    Report

    Report Number
    3004209178-2014-20658
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 9, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777-60, SERIAL# (B)(4) IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-29, LOT# N325886, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-39, LOT# N323753, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37744, SERIAL# (B)(4) PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4) PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COMMUNICATION PROBLEM. THE MANUFACTURER¿S REPRESENTATIVE (REP) COULD NOT ESTABLISH COMMUNICATION WI TH THE IMPLANTABLE NEUROSTIMULATOR (INS) USING THE CLINICIAN PROGRAMMER, IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR), OR PATIENT PROGRAMMER (PP). AN INS OVERDISCHARGE WAS SUSPECTED. THE LAST TIME ANY STIMULATION WAS FELT WAS LESS THAN ONE MONTH PRIOR TO THE REPORT. THE PATIENT LOST STIMULATION ABOUT THREE WEEKS PRIOR TO THE REPORT. THE REP. TRIED A PHYSICIAN MODE RECHARGE (PMR) WHICH RAN FOR THREE MINUTES AND THEN A POWER ON RESET (POR) SCREEN APPEARED. THE INS WAS INTERROGATED WITH THE CLINICIAN PROGRAMMER AND SAW THE INS WAS ¿DISCHARGED.¿ THE REP. WAS NOW CHARGING THE INS. IT WAS REVIEWED TO CHARGE UP TO AT LEAST 25% AND THEN CLEAR THE POR MESSAGE. THE LIKELIHOOD OF THE OVERDISCHARGE EVENT TRIGGERED WAS PROBABLY LOW IF THE INFORMATION PROVIDED BY THE PATIENT WAS ACCURATE. IT WAS REPORTED THAT STIMULATION WAS TURNING OFF AT RANDOM TIMES; ANY FURTHER DETAILS ABOUT THIS WERE UNKNOWN AT THE TIME OF THE REPORT. THE CAUSE OF THE EVENT WAS BELIEVED TO BE THE PATIENT LETTING THE BATTERY RUN LOW AND NOT CHARGING SOON ENOUGH. THE REP. MET WITH THE PATIENT AFTER THE PATIENT CHARGED HER BATTERY TO 100% AND STIMULATION WAS TURNED BACK ON. THE PATIENT SAID IT FELT GREAT AND (ADJUSTMENTS WERE MADE. THE PATIENT WAS DOING WELL NOW THAT STIMULATION WAS TURNED BACK ON AND CHARGED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696948 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