BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 22214991 · Received June 16, 2025

    Report

    Report Number
    3004209178-2025-10263
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    August 30, 2021
    Report Date
    June 16, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 977A260, LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2021, PRODUCT TYPE LEAD PRODUCT ID 977A260, LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2021, PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 04-JUN-2025, UDI#: (B)(4) ; PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 04-JUN-2025, UDI#: (B)(4). 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

    THE PATIENT REPORTED A LACK OF RELIEF SINCE IMPLANT, NOTING THEY HAD A FALL WITHIN THE LAST YEAR, BUT HAS NEVER HAD PAIN RELIEF SINCE IMPLANTED. A RETURN OF PAIN WAS NOTED. HIGH IMPEDANCES WERE DISCOVERED WITH THE FOLLOWING CONTACT READINGS: 3: 30880, 8: 30880, 9: 30930, 10: 30980, 11: 31030, 12:31080, 14: 30980, 15: 31080. THE REP REPROGRAMMED THE PATIENT AVOIDING ALL CONTACTS WITH HIGH IMPEDANCES. THE CAUSE IS UNKNOWN, AND THE ISSUE IS ONGOING. NO ADDITIONAL ACTIONS/INTERVENTIONS PLANNED, BUT THE REP NOTED THEY WOULD SUBMIT ANY NEW INFORMATION THAT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977253 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male "SEE H11...."