BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4132530 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18063
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-45, LOT# V619050, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3888-56, LOT# V392793, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V619050, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3888-56, LOT# V360223, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) IN RESPONSE TO FOLLOW-UP REPORTED THAT IMPEDANCES WERE CHECKED AND WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT¿S ACTIVITY INCREASED, REQUIRING INCREASED AMPLITUDE SETTINGS. THE PATIENT WAS SATISFIED WITH THE STIMULATION PATTERN. THE PATIENT WAS ENCOURAGED TO CHARGE MORE OFTEN TO KEEP FROM HAVING A LONG CHARGE TIME ASSOCIATED WITH CHARGING A DEPLETED BATTERY. IT WAS NOTED THAT THEY HAD HAD A ½ DEPLETED BATTERY AT THE MEETING. NOTHING WAS WRONG WITH THE DEVICE; CHARGING PROTOCOL NEEDED TO REVIEWED AND REINFORCED. THE PATIENT WAS HAPPY WITH THE RESULTS AND WAS RECEIVING ADEQUATE/SATISFACTORY THERAPY.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT IT WAS TAKING LONGER TO CHARGE HIS IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT HE WAS ALWAYS ABLE TO GET 8 COUPLING BOXES DARKENED. HE WAS ALSO FEELING A TINGLING SENSATION ON BOTH SIDES WHILE RECHARGING THAT ALSO WOULD LINGER AFTER RECHARGING WAS FINISHED. HE HAD ALWAYS FELT TINGLING BUT IT HAD CHANGED TO BE STRONGER. THIS WAS NOTED TO BE SUDDEN. IT WAS NOTED THAT THERE HAD BEEN NO CHANGE TO HIS PROGRAMMING OR SETTINGS AND NO PREVIOUS OVERDISCHARGE HAD OCCURRED. THE PATIENT HAD AN APPOINTMENT WITH A MANUFACTURER REPRESENTATIVE (REP) TO CHECK THE DEVICE ON (B)(6) 2015. RELEVANT MEDICAL HISTORY INCLUDED FAILED BACK SURGERY SYNDROME. FOLLOW-UP WAS PERFORMED TO DETERMINE WHAT ACTIONS WERE TAKEN TO ADDRESS THE EVENT AND IF IT WAS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL OFF A LADDER A ¿COUPLE 3¿ DAYS OR ABOUT 4 DAYS PRIOR TO THE NOTIFIED DATE, AND SINCE THE FALL THE DEVICE DIDN¿T SEEM TO BE WORKING LIKE IT SHOULD, THE THERAPY WAS NOT WORKING AS EXPECTED AND HAD LESS THAN 50% THERAPY RELIEF. THE PATIENT FELL ON HIS BACK AND HAD PAIN IN HIS TAILBONE FROM THE FALL ALONG WITH SEVERAL SCRAPES AND BRUISES. THE PATIENT WAS GETTING PAIN IN BOTH HIPS THAT WOULD COME AND GO. USUALLY WHEN THE PATIENT WOULD CHARGE HIS IMPLANTABLE NEUROSTIMULATOR (INS) HE WOULD GET A TINGLING SENSATION AS SOON AS HE WOULD PUT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) ON; HOWEVER THIS DIDN¿T HAPPEN THE DAY PRIOR. IT SEEMED TO TAKE TWICE AS LONG FOR HIM TO CHARGE UP HIS INS. HE HAD TO TURN STIMULATION WAY UP BEFORE HE COULD FEEL ANY STIMULATION. HE FELT AROUND HIS BACK AND DIDN¿T FEEL LIKE A DENT OR ANYTHING SO HE WAS WONDERING IF HE MOVED A WIRE OR SOMETHING. IT WAS NOTED THAT THE PATIENT HAD A PERIPHERAL NERVOUS SYSTEM (PNS) SYSTEM. THE PATIENT WANTED TO MEET WITH A MANUFACTURING REPRESENTATIVE FOR A DEVICE CHECK AND PROGRAMMING. A MEETING WAS SCHEDULED FOR (B)(6) 2014. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THIS REPORT. WHEN THEY MET, IMPEDANCE TESTING WAS PERFORMED AT 3.00 V, AND IMPEDANCES WERE WITHIN NORMAL LIMITS, EXCEPT FOR: 0<(>&<)>14 = 7366 OHMS; 0<(>&<)>15 = 14,692; 4<(>&<)>15 = 16484; 5<(>&<)>14 = 6982; 5 <(>&<)>15 = 14,692. THE PATIENT ALSO MENTIONED HE FELT BURNING AT POCKET SITE AND LEFT SIDE, BUT THAT WAS DENIED AT THIS TIME. THE PATIENT WAS THEN HAD 50% OR GREATER SYMPTOM REDUCTION, WAS DOING FINE, AND HE WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611832 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