BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4171451 · Received October 14, 2014

    Report

    Report Number
    3004209178-2014-19691
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 25, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) .

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET (POR) OCCURRED. THE CAUSE OF THE POR WAS NOT DETERMINED. IT WAS UNKNOWN WHAT ERROR CODE ACCOMPANIED THE POR. THE PATIENT¿S STIMULATION HADN¿T WORKED AND THERE WAS NO STIMULATION FOR OVER 2 YEARS. IT HAD BEEN OVER 2 YEARS SINCE LAST SUCCESSFUL CHARGE. THERE WAS LESS THAN 50% THERAPY RELIEF. THE BATTERY APPEARED TO BE OVERDISCHARGED. THE CAUSE OF THE OVERDISCHARGE WAS UNKNOWN, AND IT WAS UNKNOWN HOW MANY OVERDISCHARGES HAD OCCURRED IN THE PAST. THE PATIENT THOUGHT HE HAD DONE POR TWICE BEFORE, BUT SINCE IT WAS UNKNOWN THE MANUFACTURING REPRESENTATIVE ATTEMPTED ANOTHER POR. DIAGNOSTIC TESTING AND TROUBLESHOOTING WAS PERFORMED WHEN THEY ATTEMPTED TO INTERROGATE WITH THE 8840 AND THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR). A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED UNSUCCESSFULLY. IT WAS UNKNOWN IF THE BATTERY HAD REVIVED FROM THE OVERDISCHARGED STATE OR NOT. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THIS REPORT. FIVE (5) DAYS LATER, THE PATIENT WAS NOT ABLE TO FULLY RECHARGE HIS INS. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY BECAUSE THE DEVICE WAS NOT FUNCTIONAL. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STOPPED USING THE STIMULATOR TWO YEARS AGO BECAUSE IT WAS NOT AS EFFECTIVE. IT WAS NOTED THAT THAT IT APPEARED THE LEAD HAD MIGRATED INFERIORLY AND THE HEALTH CARE PROFESSIONAL WAS NOT SURE IT WOULD PROVIDE THERAPEUTIC EFFECT IN THAT POSITION. IT WAS NOTED THAT THE PATIENT WOULD NOT PROCEED WITH SURGERY TO EVALUATE THE LEAD. THE PATIENT OPTED FOR CONSERVATIVE THERAPY DUE TO HIS AGE AND OTHER MEDICAL CONDITIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE OVERDISCHARGE WAS DUE TO "DEVICE MALFUNCTION." IT WAS NOTED THAT THE PATIENT HAD PROBLEMS CHARGING THE DEVICE STARTING THREE YEARS PRIOR TO THE REPORT. THEY ATTEMPTED TO JUMPSTART THE BATTERY ON (B)(6) 2014 WITHOUT SUCCESS. IT WAS NOTED THAT THIS WAS THE PATIENT'S THIRD OVERDISCHARGE. THE PATIENT RESIGNED TO SEEK OTHER NON-SURGICAL OPTIONS FOR BACK/LEG PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650322 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1