BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 22807582 · Received August 14, 2025

    Report

    Report Number
    3004209178-2025-13851
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 14, 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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2017 EXPLANTED: (B)(6) 2025 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: 06-FEB-2021, 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

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS HIGH IMPEDANCES WERE OBSERVED AND THE PATIENT EXPERIENCED A LOSS OF STIMULATION. REPREPORTS IMPEDANCES OF CONTACT 12: 1110, CONTACT 13: 1160, CONTACT 14: 1170, AND CONTACT 15: 1160. REP REPORTS THE CAUSE IS UNKNOWN. REP REPORTS THEY WERE TOLD THERE WAS GOING TO BE A BATTERY REPLACEMENT BUT WHEN THEY ARRIVED THEY WERE INFORMED THAT THEY WERE REPLACING ONE OF THE PATIENT'S LEADS. REP CHECKED THE IMPEDANCES AND SAW THE PATIENT HAD CONTACTS 12 THROUGH 15 WITH HIGH IMPEDANCES. REP REPORTS THE LEAD WAS REPLACED AND THIS RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556791 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention "SEE H11...."