BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 21504810 · Received March 3, 2025

    Report

    Report Number
    2182207-2025-00592
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Report Date
    April 17, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-1535-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 97755-S, SERIAL/LOT #: (B)(6), MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE [RECHARGER], MODEL [97755], S/N [(B)(6)], REVEALED INTERMITTENT NO DEVICE FOUND MESSAGE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PATIENT REPORTED THE CHARGING DEVICE WAS NOT WORKING PROPERLY FOR MONTHS. PATIENT SAID THEY HAD BEEN SITTING FOR 3 HOURS AND THE IMPLANTED NEUROSTIMULATOR (INS) HAD ONLY GOTTEN TO 50%. PATIENT SAID SOMETIMES THE CONTROLLER COULD FIND THE STIMULATOR AND SOMETIMES IT COULDN'T. PATIENT ALSO SAID THEY COULD HEAR A CLICKING NOISE WHEN THEY PLUGGED THE CONTROLLER INTO THE RECHARGER. AGENT ASKED IF THERE WERE ANY SPECIFIC ERROR MESSAGES AND PATIENT SAID SOMETIMES IT WOULD SAY IT NEEDED ATTENTION AND COULDN'T FIND IT. PATIENT MENTIONED THEY HAD TO TAKE THE BATTERY OUT AND DO ALL KINDS OF THINGS TO GET THE CONTROLLER TO FIND THE IMPLANT. AGENT ASKED, PATIENT CONFIRMED NO DEVICE FOUND. WHEN ASKED FOR EVENT DATE, PATIENT SAID FROM THE BEGINNING THEY HAD CALLED IN AT THE BEGINNING BEFORE AND WOULD FIDDLE WITH IT UNTIL THEY GOT IT TO WORK, BUT TODAY THEY WERE JUST FED UP WITH THE EQUIPMENT AND ANNOYED. SEE PREVIOUS CASES. PATIENT CONFIRMED THE CONTROLLER BATTE RY WAS ALMOST COMPLETELY LOW AFTER THEY CHARGED IMPLANT THIS MORNING. PATIENT STATED WHEN THEY STARTED CHARGING AFTER SEEING NO DEVICE FOUND, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN THE RED. AGENT REVIEWED INFORMATION ABOUT THE NO DEVICE FOUND SCREEN. PATIENT THEN SAID IT HAD BEEN JUST SHY OF 3 HOURS SINCE THEY STARTED CHARGING AND THE IMPLANT WAS ONLY AT 70% AND THE CONTROLLER WAS ALMOST EMPTY. PATIENT ASKED IF THE QUALITY WOULD EVER GO AWAY ENTIRELY WHEN IT JUST SAID RECHARGING; PATIENT SAID THE SCREEN WOULD SHUT DOWN AND THEY COULDN'T SEE IT ALL THE TIME, BUT WHEN THEY PICKED THE CONTROLLER UP, THE CONTROLLER WOULD SAY RECHARGING EXCELLENT AND THEN IT WOULD BEEP AND SAY CHARGING NEEDS TO BE ADDRESSED OR WHATEVER IT SAID. AGENT HAD PATIENT RESET THE CONTROLLER AND THEN START A CHARGING SESSION. PATIENT ENTERED PASSIVE RECHARGE MODE AND REPORTED SEEING NUMBERS 21-21-21. PATIENT REPOSITIONED THE PADDLE AND SAW NUMBERS 19-87-97. PATIENT NOTED THE PADDLE WAS GETTING PRETTY WARM. AGENT ASKED, PATIENT STATED SOMETIMES THEY HAVE TO STOP CHARGING AS THE RECHARGER PADDLE GETS SO HOT. PATIENT ALSO STATED THE RECHARGER IS DIFFICULT TO PLUG INTO THE CONTROLLER, BUT THERE WERE NO ISSUES PLUGGING THE POWER SUPPLY INTO THE CONTROLLER. PATIENT UNPLUGGED AND INSPECTED RECHARGING ANTENNA CORD/PLUG AND CONTROLLER PORT, BUT DID NOT SEE ANY DAMAGE. PATIENT REINSERTED RECHARGER AND STATED PASSIVE RECHARGE MODE NUMBERS WENT TO 87 FOR ALL 3 NUMBERS. THE ISSUE WAS NOT RESOLVED. A REPAIR REQUEST WAS SENT TO REPLACE THE RECHARGER. PATIENT CONFIRMED ISSUES HAVE PERSISTED SINCE THEY WERE FIRST IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697002 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female SEE H11