BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8735751 · Received June 26, 2019

    Report

    Report Number
    3004209178-2019-12406
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    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 WAS RECEIVED ON JUNE 25, 2019 FROM THE PATIENT AND A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT AROUND (B)(6) 2019 THE PATIENT STARTED NOTICING AN INCREASE IN PAIN IN THEIR NORMAL PAIN AREA. THEY ALSO NOTICED THEIR DEVICE WAS TURNING OFF ON ITS OWN. IT WAS NOTED THAT ON (B)(6) 2019, THE PATIENT HAD CHARGED IN THE EVENING AND WHEN THEY WOKE UP ON (B)(6), THE CHARGE WAS AT 10% AND THERAPY WAS OFF. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAS BEEN CHARGING FREQUENTLY / TOO OFTEN. THEY WERE CHARGING 2-3 TIMES A DAY. IT WAS CONFIRMED THAT THE PATIENT HADN'T HAD RECENT REPROGRAMMING OR SWITCHED GROUPS. THE PATIENT MET WITH THE REP ON (B)(6) 2019 TO CHECK PROGRAMMING AND RECHARGE STATISTICS. IT WAS CONFIRMED THAT ADAPTIVE STIM WAS NOT ON. THE RECHARGE DATA SHOWED THERE WERE MULTIPLE CHARGE SESSIONS THAT STARTED WITH THE INS CHARGE AT 10%. THE DEVICE DATE WAS FOUND TO BE SET AT (B)(6) 2011 (IMPLANT DATE WAS (B)(6) 2018), AND THE RECHARGE STATS INDICATED THERE WERE RECHARGING SESSIONS ON (B)(6) 2018. GIVEN THAT THE DEVICE DATE WAS INCORRECT, THE EXACT DATES OF RECHARGING COULD NOT BE CONFIRMED. THE DATA SHOWED THAT THE PATIENT HAD 23 CHARGING SESSIONS 20%-"705" WITH FAIR COUPLING, 30-80% WITH GOOD COUPLING, AND A THIRD TIME 30%-100% EXCELLENT COUPLING. THE PATIENT'S LAST CHARGING SESSION WAS 1.3 HOURS AND WENT FROM 10%-100% CHARGE. THE REP ALSO CHECKED THE ENERGY METER AND REPORTED THE FOLLOWING SETTINGS: USING 4, 5 CONTACTS, 200 PULSE WIDTH, 1000 HERTZ, WHICH YIELDED A RECHARGE INTERVAL OF 0.6 DAYS. THIS APPEARED TO BE APPROPRIATE AND ALIGNED WITH HOW OFTEN THE PATIENT REPORTED CHARGING. IMPEDANCES WERE CHECKED AND FOUND TO BE WITHIN THE NORMAL RANGE (800-1090 OHMS) EXCEPT FOR CONTACTS 2 AND 15, WHICH WERE SHORTS AT 190 OHMS. IT WAS NOTED THAT NEITHER OF THESE CONTACTS WERE BEING USED IN THE PATIENT'S PROGRAMMING. THE REP TRIED REPROGRAMMING AND NOTED THAT THE PATIENT USED TO BE AROUND 3.5 MILLIAMPS (MA) BUT NOW THEY WERE UP TO 7-10 MA BUT THE PATIENT WASN'T FEELING STIMULATION. IT WAS REVIEWED THAT THE PATIENT START CHARGING WHEN THE CHARGE GETS TO 30% TO AVOID IT GETTING SO LOW WHERE THERAPY TURNS OFF, AND THAT TECHNICAL SERVICES SUSPECTS THAT WAS THE REASON WHY THE DEVICE WAS RANDOMLY TURNING OFF. THE DEVICE DATE WAS CORRECTED DURING THE CALL AND IT WAS REVIEWED THAT NOW WITH THE CORRECT DATE, IT WOULD BE EASIER TO TRACK CHARGING DATES AND STARTING/ENDING BATTERY CHARGE LEVELS AND CAN BE COMPARED TO ANY FUTURE EVENTS WHERE THE STIMULATION TURNS OFF. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. INFORMATION WAS REPORTED THAT THE PATIENT REPORTED THE INS JUST GOES OFF/ON, ON ITS OWN. THE PATIENT STATED THAT THE TRIAL WORKED WELL TO CONTROL THEIR PAIN, BUT SHE FEELS LIKE NOW IT'S INTERMITTENT. THE PATIENT DOES NOT HAVE ADAPTIVE STIMULATION (AS) AND DENIES ANY RECENT FALLS OR TRAUMA. THE PATIENT'S PAIN RELIEF IS INTERMITTENT. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE INDICATED THAT THE PATIENT HAS NOT BEEN GETTING GOOD PAIN RELIEF FOR THE LAST 6 WEEKS. THE REP REPROGRAMMED THE PATIENT TO TRY AND IMPROVE PAIN RELIEF, AND THEY ADDED CYCLING TO IMPROVE RECHARGE INTERVAL. THE REP STATED THAT AS OF (B)(6) 2019, THE SYSTEM IS WORKING MUCH BETTER FOR THE PATIENT. HOWEVER, THE PATIENT IS GETTING AN X-RAY TO CHECK THE LEAD PLACEMENT. THE REP NOTED THAT THERE ARE NO SURGICAL INTERVENTIONS AT THIS TIME. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529342 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR