BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 20498727 · Received October 21, 2024

    Report

    Report Number
    3004209178-2024-20679
    Event Type
    Malfunction
    Date Received
    October 21, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 21, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME SPECIFY SURESCAN; PRODUCT ID 977C265 (SERIAL: (B)(6); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2024; EXPLANT DATE 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

    CALLER IS MANUFACTURER REPRESENTATIVE AND REPORTS PATIENT IS SEEING SETTING NOT AVAILABLE CANNOT PROVIDE YOUR DESIRED INTENSITY SETTINGS FOR ABOUT 1 MONTH. CALLER REPORTS PATIENT NEEDS COVERAGE FOR BOTH LEFT AND RIGHT. CALLER REPORTS PATIENT HAD STIMULATION OFF. CALLER IMPEDANCE IS SHOWING OPEN AND DO NOT USE IMPEDANCE. CALLER REPORTS PATIENT IS PROGRAMMED WITH ELECTRODES: 0,1,2,3,8,9,10, 11 ELECTRODE IMPEDANCE SHOWS: REFERENCE 1 2: 3850 OHMS 3: 19610 OHMS 8: 4010 OHMS 9: 3370 OHMS 10: 4050 OHMS 11: 19660 OHMS REFERENCE 2 3: 18380 OHMS 8: 4410 OHMS 9: 3910 OHMS 10: 3540 OHMS 11: 19020 OHMS REFERENCE 3 8: 18620 OHMS 9: 18470 OHMS 10: 4460 OHMS 11: 4500 OHMS REFERENCE 8 9: 3920 OHMS 10: 18420 OHMS 11: 20160 OHMS REFERENCE 9 10: 3840 OHMS 11: 19660 OHMS REFERENCE 10 11: 18620 OHMS. CALLER REPORTS NO FALL OR TRAUMA. CALLER REPORTS XRAY WAS PERFORMED AND SHOWS THERE IS A KINK AND THE LEAD HAD MOVED DOWN A LITTLE BIT. CALLER REPORTS NO OLD X-RAY TO COMPARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286563 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown SEE H11...