BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3961541 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13593
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 3, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. IT WAS NOTED THAT A COMMUNICATION PROBLEM WAS REPORTED. IT WAS FURTHER NOTED, THE PATIENT TRIED ADJUSTING THE ANTENNA DIAL AND REPOSITIONING THE ANTENNA OVER THE INS SITE. IT WAS NOTED, THE LAST TIME THE PATIENT FELT STIMULATION WAS ABOUT ONE WEEK AGO. IT WAS FURTHER NOTED, THE LAST SUCCESSFUL RECHARGING SESSION WAS THREE WEEKS AGO. THE REPORTER STATED THAT YESTERDAY, THEY SAT DOWN VERY QUICKLY AND THEY HEARD SOMETHING CLICK IN THEIR BACK. THE REPORTER FURTHER STATED THAT SINCE THEN THEY HAD FELT A DULL ACHE IN THE MIDDLE OF THE BACK IN THE AREA OF WHERE THE ¿WIRES¿ WERE IMPLANTED. IT WAS NOTED, THE PATIENT STATED THAT STIMULATION HELPED WITH THEIR PAIN. IT WAS FURTHER NOTED THAT SOMETIMES, THE PATIENT WAS MORE ACTIVE THAN NORMAL AND THE DAY AFTER BEING MORE ACTIVE THEY WERE SORE. ADDITIONAL INFORMATION RECEIVED REPORTED, THE MANUFACTURING REPRESENTATIVE COULD NOT COMMUNICATE WITH THE INS USING ANY EXTERNAL DEVICE. ADDITIONAL INFORMATION RECEIVED REPORTED THE OVERDISCHARGE WAS CONFIRMED. THE REPORTER STATED, THE LAST SUCCESSFUL OVERDISCHARGE WAS CONFIRMED. THE REPORTER STATED, THE CAUSE OF THE OVERDISCHARGE WAS PATIENT COMPLAINT AS THE PATIENT FAILED TO CHARGE THE INS. IT WAS NOTED, THE PATIENT HAD A LACK OF STIMULATION. IT WAS FURTHER NOTED, THE MANUFACTURING REPRESENTATIVE ATTEMPTED TO INTERROGATE WITH THE CLINICIAN PROGRAMMER, BUT THE INS WAS UNRESPONSIVE. THE REPORTER STATED, THE PATIENT WAS INSTRUCTED ON HOW TO CHARGE IN PHYSICIAN MODE. THE REPORTER FURTHER STATED, THE PATIENT RECHARGED FOR FOUR HOURS WITHOUT SUCCESS. IT WAS NOTED, THE PATIENT WAS UNABLE TO GET THE BATTERY CHARGED ENOUGH TO CHARGE IN NORMAL MODE. THE REPORTER STATED, THEY RE-EDUCATED THE PATIENT MODE ON HOW TO CHARGE IN PMR MODE AND THEY WOULD FOLLOW UP WITH THE PATIENT LATER. ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT NOTICED THE RECHARGER WAS FULLY CHARGING THE INS EVEN WHEN THEY HAD IT OVER ALL NIGHT. THE REPORTER STATED, IT WAS DEPLETING MORE RAPIDLY. THE REPORTER FURTHER STATED, IT HAD ONLY BEEN 1-2 WEEKS SINCE THEY LAST RECHARGED. IT WAS NOTED, THE PATIENT MET WITH A MANUFACTURING REPRESENTATIVE ON 2014 (B)(6) AND THEY SHOWED THE PATIENT HOW TO DO A PHYSICIAN MODE RECHARGER (PMR). IT WAS FURTHER NOTED, THE PATIENT WAS DIRECTED TO DO A PMR AT HOME. THE REPORTER STATED THEY DID THE PMR FOR FIVE HOURS AND THEY WERE STILL NOT ABLE TO RECHARGE. THE REPORTER FURTHER STATED, THE MANUFACTURING REPRESENTATIVE DID TRY A DIFFERENT RECHARGER AT THEIR APPOINTMENT. IT WAS NOTED, THE PATIENT WAS SUPPOSED TO MEET WITH THE MANUFACTURING REPRESENTATIVE ON 2014 (B)(6), BUT THEY FORGOT ABOUT THE APPOINTMENT AND THEY HAD TRANSPORTATION PROBLEMS. THE REPORTER STATED, THE MANUFACTURING REPRESENTATIVE CALLED THEM AND THEY WERE NOT ABLE TO DO ANYTHING MORE FOR THE SITUATION. IT WAS NOTE,D THE PATIENT¿S NEXT APPOINTMENT WAS SCHEDULED FOR 2014 (B)(6). IT WAS FURTHER NOTED, THE PATIENT DID NOT TELL THEIR HEALTHCARE PROFESSIONAL ABOUT THE ¿CLICK¿ THEY HEARD IN THEIR BACK AND THE PAIN HAD GONE AWAY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE TELEMETRY ISSUES. THE REPORTER STATED THEY HAD BEEN WORKING ON TRYING TO RESOLVE THE INS OVERDISCHARGE FOR ALMOST A WEEK. THE REPORTER FURTHER STATED, THE PATIENT HAD DONE FIVE PMRS ON THEIR OWN AND THERE WAS STILL NO RESPONSE FROM THE INS. IT WAS NOTED THAT PROBLEM WITH RECHARGE COUPLING WAS THE PRIMARY REASON FOR OVERDISCHARGE. IT WAS FURTHER NOTED, THE PATIENT INDICATED THAT IT HAD BEEN A MONTH SINCE THEY LAST USED THE SYSTEM. THE REPORTER STATED, THE PATIENT WAS HAVING TROUBLE CHARGING BEFORE THE OVERDISCHARGE. THE REPORTER FURTHER STATED THAT IT WOULD TAKE HOURS FOR THE PATIENT TO RECHARGE AND THE INS WOULD BARELY CHARGE UP. IT WAS NOTED THE PATIENT WAS GETTING POOR COUPLING WITH 1-2 BARS. IT WAS FURTHER NOTED, THE PATIENT WAS GETTING EIGHT COUPLING BARS AFTER IMPLANT. THE REPORTER STATED, THE PATIENT GAINED 40 POUND SINCE IMPLANT. THE REPORTER FURTHER STATED, THE INS FELT DEEP WHEN THEY TRIED TO PALPATE IT. IT WAS NOTED, THE CHANGE IN COUPLING WAS GRADUAL. IT WAS FURTHER NOTED, THE INS WAS IMPLANTED IN THE PATIENT¿S FLANK. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT COULD NOT RECHARGE THEIR DEVICE BECAUSE THE INS BECAME TOO DEEP AFTER THE PATIENT GAINED 40 POUNDS. IT WAS NOTED, THE DEVICE WAS NOT FLIPPED. IT WAS FURTHER NOTED, THE PATIENT WOULD HAVE A POCKET REVISION TO CORRECT THE PROBLEM. THE REPORTER STATED THE PATIENT WAS NOT SCHEDULED FOR SURGERY UNTIL (B)(6). ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BATTERY REPLACEMENT ON (B)(6). THE DEVICE WAS NOT FLIPPED. THE DOCTOR REVISED THE POCKET AND A NEW STIMULATOR WAS IMPLANTED. THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETION WAS NORMAL BUT THE PATIENT HAD DISSATISFACTION WITH THE LONGEVITY. THE INS WAS IMPLANTED IN (B)(6) 2013 AND THE BATTERY HAD DEPLETED IN (B)(6) 2014. THE HEALTHCARE PROFESSIONAL HAD TOLD THE PATIENT THAT THE BATTERY WAS DEAD. PRIOR TO THE BATTERY BEING DEPLETED IT WAS TAKING LONGER AND LONGER TO CHARGE THE INS. IT WAS NOTED THAT THE PATIENT¿S WEIGHT GAIN COULD BE THE CAUSE FOR A POOR CONNECTION, HE HAD GAINED 20 POUNDS. NO OUTCOME WAS 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 AFTER THE REVISION, THE PATIENT WAS ABLE TO CHARGE EFFECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437926 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 00052 YR Required Intervention