BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 21310065 · Received February 5, 2025

    Report

    Report Number
    3004209178-2025-02068
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-1535-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, 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. 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.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE [RECHARGER], MODEL [97755], S/N [(B)(6)], REVEALED RECHARGE ANTENNA FAILURE AND NO DEVICE FOUND MESSAGE X 2. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY ARE HAVING TROUBLE CHARGING THE IMPLANTED NEUROSTIMULATOR SINCE 2 WEEKS AGO. PATIENT STATED IT IS GETTING HARDER AND HARDER TO CHARGE THE IMPLANT AND WHEN THEY FINALLY GET THE IMPLANT TO CHARGE, THE CONTROLLER IS FULLY CHARGED WHEN THEY START CHARGING AND CONTROLLER IS DRAINED AND INS IS NOT CHARGE UP. PATIENT REPORTED THE RECHARGER PADDLE IS BURNING THEIR SKIN ALMOST INSTANTLY WHEN THEY ARE CHARGING THE IMPLANT. PATIENT CONFIRMED THERE IS NO TISSUE DAMAGE ON THE SKIN. PATIENT STATED THEY GET SYSTEM PROBLEM RM03 FEW DAYS AGO WHEN CHARGING THE INS AGENT ASKED PATIENT TO CONNECT WITH THE CONTROLLER AND CONTROLLER SHOW IMPLANTED NEUROSTIMULATOR 60%, CONTROLLER 100% CHARGED. PATIENT SERVICE ASKED PATIENT IF THERE IS ANY VISIBLE DAMAGE TO THE CONTROLLER PORT AND PATIENT SAID NO. AGENT ASKED PATIENT TO INSPECT THE RTM FOR DAMAGE AND PATIENT SAID THERE IS NO DAMAGE ON THE RTM. THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE RECHARGER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362969 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female "SEE H11...."