BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 24334030 · Received February 13, 2026

    Report

    Report Number
    3004209178-2026-02402
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 6, 2026
    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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6. 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

    CONTINUATION OF D10: PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2014 EXPLANTED: (B)(6) 2026 PRODUCT TYPE LEAD PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2014 EXPLANTED: (B)(6) 2026 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: 26-AUG-2018, UDI#: (B)(4) ; PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 26-AUG-2018, 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 IMPLANTED NEUROSTIMULATOR (INS). THE REP REPORTED THAT ALL IMPEDANCES DISPLAYED 40000 13/15 CONTACTS AND HAD A RED "X" AND 2 CONTACTS HAD AN ORANGE "!". THE REP REPORTED THAT THE LEADS REQUIRED REPLACEMENT DUE TO HIGH IMPEDANCES, HOWEVER FULL SYSTEM WAS EXPLANTED. REP WAS MADE AWARE OF FULL SYSTEM IMPEDANCE ISSUES TODAY IN PRE-OP. THE ISSUE WAS RESOLVED. THE REP NOTED THEY WILL SUBMIT ANY NEW INFORMATION THAT THEY BECOME AWARE OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28039 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1