BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2955219 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02512
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 24, 2013
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37714, SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS INSTRUCTED ON NOT RECHARGING HER IMPLANTABLE NEUROSTIMULATOR (INS) AND ON LETTING IT GO COMPLETELY DEAD AND NOT USING THE STIMULATION. THE PATIENT HAD DONE THIS AND HER LEG PAIN WAS BACK BUT THE PAIN IN THE INS POCKET WAS BETTER. IT WAS REPORTED THAT THE PATIENT WAS OVERALL VERY SENSITIVE AND HAD A LOT OF POST OP PAIN AS WELL. IT WAS REPORTED THAT ADAPTIVE STIMULATION WASN'T TURNED ON UNTIL 5-6 WEEKS AFTER THE IMPLANT AND THE PATIENT OPTED NOT TO USE IT. IT WAS REPORTED THAT IN THE PAST PRIOR TO THAT THE STIM (UNCLEAR IF REFERRING TO INS, ADAPTIVE STIMULATION, OR JUST STIMULATION) HAD BEEN USED A GOOD AMOUNT. IT WAS REPORTED THAT THE PATIENT LIKED THE THERAPY AND THAT IT HELPED HER. TWO DAYS LATER, IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION THAT LASTED A MINUTE OR TWO IN THE MIDDLE OF THE NIGHT ONE DAY BEFORE THE REPORT FOLLOWING THE APPOINTMENT WHERE THE PATIENT HAD THE CHARGER ON THE IMPLANT FOR LESS THAN 5 MINUTES TO REVIEW STIM ON/OFF BUTTONS. THERE WAS ALSO A BURNING SENSATION EVEN THOUGH THE INS WAS CONFIRMED TO BE IN A DISCHARGE STATE PER CLINICIAN PROGRAMMER ON THE DAY OF THE REPORT. TWO DAYS PRIOR TO THE REPORT, NO PAIN AT INS SITE WAS REPORTED. IT WAS STATED THAT AS THE BATTERY WAS DEPLETING THE PATIENT HAD MOMENTS OF THE SITE BURNING OR IF SHE WAS LAYING DOWN OR SITTING. IT WAS STATED SHE HAD STIMULATION DOWN TO 0.0 V ON PROGRAMS A AND B. THE PATIENT WAS THEN ADVISED BY HER HEALTHCARE PROFESSIONAL (HCP) TO CHARGE THE INS UP TO 25% AND THEN COME IN ON THE DAY OF THE REPORT SO THAT THE BATTERY COULD BE INTERROGATED FOR IMPEDANCES, SOME REPROGRAMMING, AND TRY DIFFERENT POSITIONS, ETC. TO TRY AND DETERMINE THE CAUSE. IT WAS CONFIRMED THE INS WAS IN "DISCHARGE" PER CLINICIAN PROGRAMMER. NONE OF THE COMPONENTS WOULD COMMUNICATE WITH THE INS. THE PATIENT WAS TERRIFIED TO RECHARGE AND TURN THE SYSTEM BACK ON GIVEN THE PAIN AND BURNING SENSATION SHE HAD AT THE SITE WHEN IT OCCURRED. IT WAS STATED THAT THE PATIENT HAD A DIFFICULT TIME DURING THE HEALING PROCESS AS THE PAIN WAS EXCRUCIATING EVEN THOUGH TUNNELING 3" ONLY FOR THE LEAD WAS NEEDED. IT WAS STATED GIVEN ALL PATIENT'S SURGERIES THAT THIS ONE WAS THE WORST FOR THE PAIN. IT WAS ALSO STATED THAT THE EVENT OR SYMPTOMS OCCURRED FOLLOWING A FALL. THE PATIENT HAD FALLEN BACK IN (B)(6) 2012, PRIOR TO REPROGRAMMING OF ADAPTIVE STIMULATION. THE PATIENT FELL FLAT ON HER FACE AND SIDE. THERE WERE NO OTHER REPORTS OF ANY OTHER INCIDENT. IT WAS INDICATED THAT LAST TIME THE BATTERY WAS CHECKED IN (B)(6) 2012, AND IMPEDANCES WERE NORMAL, HOWEVER, THERE WERE NO RECORDS OF THAT TO PROVIDE. SIX DAYS LATER INTERMITTENT STIMULATION WAS REPORTED. ONE DAY LATER, ADDITIONAL INCIDENTS OF BURNING PAIN LASTING 1-2 MINUTES AT INS SITE WERE REPORTED EVEN THOUGH THE INS HAD BEEN IN DISCHARGE AS ADVISED BY PATIENT'S HCP. THE PATIENT HAD NOT USED STIMULATION DUE TO DISCHARGED STATUS. SIX DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED ON THE SAME DAY TO HAVE THE SYSTEM REMOVED. EXISTING INS WAS REMOVED, A NEW POCKET WAS CREATED AND A NEW INS WAS PUT IN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A "VERY SHARP BURNING" FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE ON THE (B)(6) PRIOR TO THE REPORT. WHEN THE PATIENT TOUCHED THE AREA, THE SENSATION GOT WORSE. THE SENSATION WENT AWAY, BUT REOCCURRED ON MONDAY. THE REPORTER STATED THAT THE PATIENT SHUT STIMULATION OFF AFTER THE SENSATION WENT AWAY ON (B)(6). IT WAS NOTED THAT THE PATIENT HAD NEVER EXPERIENCED THIS SENSATION BEFORE. ALL IMPEDANCE MEASUREMENTS WERE NORMAL AND IMPLANT SITE LOOKED "OK". THE REPORTER INDICATED THAT THE PATIENT'S THERAPY WAS WORKING WELL FOR THE PATIENT'S SYMPTOMS OTHERWISE. IT WAS NOTED THAT PATIENT'S DEVICE WAS LOCATED IN THE LOWER BACK, CLOSE TO THE LEAD LOCATION. APPROXIMATELY TWO WEEKS LATER, IT WAS FURTHER REPORTED THAT FOR THE PAST 3 WEEKS, THE PATIENT HAD EXPERIENCED 6-7 SEPARATE EPISODES (LAST ONE ON (B)(6)), WHERE SHE WOULD WAKE UP IN THE MIDDLE OF THE NIGHT FEELING A BURNING SENSATION RIGHT AROUND THE INS THAT LASTED FOR A MINUTE OR TWO, AND THEN WENT AWAY. THIS WAS NOTED TO HAVE HAPPENED WHETHER THE INS WAS ON OR OFF. WHEN THE BURNING WAS PRESENT, IT WAS "TWICE AS BAD" IF THE PATIENT TOUCHED THE AREA. THE PATIENT'S HEALTHCARE PROVIDER (HCP) RECOMMENDED ALLOWING THE INS BATTERY TO DEPLETE COMPLETELY TO SEE IF THE ISSUE PERSISTED. IT WAS HOWEVER UNCLEAR IF THIS HAD BEEN ATTEMPTED YET. THE REPORTER STATED THAT ON TWO DIFFERENT OCCASIONS, THE PATIENT HAD TURNED STIMULATION DOWN TO ZERO AND OFF USING THE PATIENT PROGRAMMER BUT THEN WENT BACK LATER TO FIND THE INS ON AND SET AT PREVIOUS PROGRAMMING SETTINGS. IT WAS NOTED THAT THE INS WAS PROGRAMMED USING "GENERIC" PROGRAMMING BECAUSE ADAPTIVE STIMULATION WASN'T ABLE TO BE CORRECTLY PROGRAMMED. THE REPORTER ALSO INDICATED THAT THE PATIENT FELT A "WARM SENSATION" IN OR AROUND THE INS POCKET DURING RECHARGING WHICH WAS A SEPARATE ISSUE FROM THE "BURNING SENSATION" THE PATIENT FELT IN THE MIDDLE OF THE NIGHT, AS SHE HAD NOT BEEN USING AN INS RECHARGER (INSR) AT NIGHT WHEN THAT "BURNING SENSATION" HAPPENED. IT WAS NOTED THAT THE PATIENT USUALLY HAD A LAYER OF CLOTHING BETWEEN THE INSR AND THE SKIN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58375 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 Required Intervention