BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8212677 · Received January 3, 2019

    Report

    Report Number
    3004209178-2019-00154
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97755, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. 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

    INFORMATION WAS RECEIVED FROM A CONSUMER AND MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS CHARGING THEIR BATTERY SINCE IMPLANT. THE HAD TRIED TO REPOSITION THE CHARGER A FEW TIMES BUT THE SAME ISSUE KEPT HAPPENING. THE PROGRAMMER SHOWED RECHARGING QUALITY WAS EXCELLENT AND THEN AFTER A FEW MINUTES IT CHANGED TO CANNOT FIND THE DEVICE. THEY GOT EXCELLENT COUPLING UNTIL THEY MOVED A BIT AND IT WOULD STOP CHARGING TO SHOW "TRY AGAIN" SCREEN. THE ISSUE WAS NOT RESOLVED. IT WAS NOTED THAT THE CHARGER WAS REPLACED BUT THE SAME ISSUE OCCURRED WITH THE NEW PRODUCT. THE PATIENT WAS DISAPPOINTED BECAUSE IT TOOK 30-45 MINUTES TO FIND THE EXACT SPOT TO CHARGE. IT TOOK OVER 4 HOURS TO CHARGE. THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD GET TO 50% AND THEN THE BATTERY PACK RAN OUT OF JUICE AND THEY WOULD HAVE TO CHARGE THE CONTROLLER BEFORE GOING BACK TO FINISH CHARGING THE INS. DURING THE CALL ON (B)(6) 2018 THE INS WAS DEAD. THE RECHARGE QUALITY SHOWED EXCELLENT AND HAD A FLASHING GREEN LIGHT ABOVE THE SCREEN. THEY WERE ON GROUP B WITH 6.5 WHICH INDICATED THEY ONLY HAD 1 PROGRAM AVAILABLE TO ADJUST. THE CONSUMER CONFIRMED THAT THEY LET THE CONTROLLER SCREEN GO DARK WHEN CHARGING WITHOUT TRYING TO WAKE IT UP AND THE INS WAS TURNED OFF DURING CHARGING. THE PATIENT WAS GOING TO FOLLOW-UP WITH THEIR HEALTH CARE PROVIDER (HCP). THE INS WAS REPORTED TO BE CLOSE TO THE SURFACE WITH THE TOP PART STICKING OUT MORE THAN THE BOTTOM PART. THE PATIENT SAW THEIR HEALTH CARE PROVIDER (HCP) THE WEEK AFTER IMPLANT. THE PATIENT WAS STILL REALLY SWOLLEN AND WERE TOLD BY THEIR PHYSICIAN THAT THE CHARGING ISSUES WERE DUE TO THE SWELLING. THE PATIENT WAS TOLD TO ICE AND TAKE AN ANTI-INFLAMMATORY. WHENEVER THEY FELT THE STIMULATION FEELING IT WAS ON THE RIGHT SIDE OF THEIR BODY AND NEVER THE LEFT. THE PATIENT HAD LEADS ON BOTH SIDES OF THEIR BODY AND STATED THAT THEY SHOULD BE FEELING STIMULATION ON BOTH SIDES. THEY HAD TRIED INCREASING STIMULATION BUT THIS DID NOT RESOLVE THE STIMULATION ISSUE. THE PATIENT HAD HD SETTINGS AND THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DIED EVERY DAY AND DID NOT LAST 24 HOURS ON A CHARGE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM PATIENT WAS RECEIVED. PATIENT STATED THE SAME ISSUE WAS HAPPENING. PATIENT WOULD GET EXCELLENT RECHARGE STATUS AND THEN LOST IT. PATIENT WAS SENT A NEW PRODUCT BUT NOT CORRECTED THE ISSUE. IT WAS REVIEWED PATIENT TO CALL INTO PATIENT SERVICES FOR TROUBLESHOOTING AND POTENTIAL NEW PRODUCT. A REPLACEMENT CONTROLLER WOULD BE SENT. IT WAS NOTED IT TOOK PATIENT 30 TO 45 MINUTES JUST TO FIND SPOT TO RECHARGE, THEN IT TOOK HER 4 HOURS TO RECHARGE. REP TOLD PATIENT TO CALL AND GOT A NEW BATTERY AND CONTROLLER. ADDITIONAL INFORMATION FROM PATIENT WAS RECEIVED ON 2019-JAN-03. PATIENT STATED INS GOT TO 50% CHARGE THEN THE LITTLE BATTERY PACK RUN OUT OF JUICE AND SHE HAD TO CHARGE THE CONTROLLER, THEN WENT BACK TO CHARGING THE INS. PATIENT TALKED TO REP ABOUT THE ISSUE OF RECHARGING THE SAME WEEK AFTER IMPLANT. NO FURTHER COMPLICATION AND EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7862 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR