BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 23819089 · Received December 16, 2025

    Report

    Report Number
    3004209178-2025-21180
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Report Date
    December 16, 2025
    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
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2021 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2021 EXPLANTED: 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: 24-JUN-2025, UDI#: (B)(4); PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 24-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 REASON FOR CALL WAS PATIENT REPORTED THAT EVERY TIME THEY NEEDED TO REPROGRAM THE THERAPY DUE TO BAD LEADS THEY WOULD GET SETTINGS NOT AVAILABLE CANNOT PROVIDE YOUR DESIRED INTENSITY SETTINGS. PT MENTIONED THAT THE ONLY WAY THE MDT REP COULD FIX WAS TO CONNECT THE DEVICE PHYSICALLY. PT MENTIONED THAT THEY MET WITH THE MDT REP "A FEW WEEKS A GO WE HAD THAT PROBLEM I HAVEN'T HAD A REPEAT PROB OF THAT SPECIFICALLY" FIXED ON (B)(6), THEY MET AGAIN (B)(6). PT CLARIFIED THAT THEY'VE BEEN GETTING THE MESSAGE SETTINGS NOT AVAILABLE CANNOT PROVIDE YOUR DESIRED INTENSITY SETTINGS SINCE THEY GOT THE DEVICE. PT MENTIONED THEY'RE A CANDIDATE FOR A REVISION; THEY NEEDED TO GET A HIP SURGERY OR A TUMMY TUCK BUT PT WANTED TO FIX THE STIMULATOR FIRST BEFORE ANY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942611 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male "SEE H11...."