BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 22805304 · Received August 14, 2025

    Report

    Report Number
    3004209178-2025-13824
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    May 13, 2025
    Report Date
    September 15, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    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 377760 LOT# V002341. IMPLANTED: (B)(6) 2006: PRODUCT TYPE LEAD PRODUCT ID 377760 LOT# N0030811. IMPLANTED: (B)(6) 2006: PRODUCT TYPE LEAD 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 377760 LOT# V002341 IMPLANTED: (B)(6) 2006 PRODUCT TYPE LEAD PRODUCT ID 377760 LOT# N0030811 IMPLANTED: (B)(6) 2006 PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377760, SERIAL/LOT #: (B)(6), UBD: 12-JAN-2010, UDI#: (B)(4); PRODUCT ID: 377760, SERIAL/LOT #: (B)(6), UBD: 28-APR-2009, 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

    REP REPORTED THAT THEY WERE INFORMED THAT THE LEADS WERE REMOVED DUE TO A SPINAL FUSION THAT WAS PERFORMED. THE LEADS WERE IN THE WAY AND THE PHYSICIAN ELECTED TO REMOVE THEM. REP WAS NOT TOLD IF THERE WAS AN ISSUE WITH THE DEVICE. THE LEADS WERE NOT SENT BACK TO REP'S KNOWLEDGE. LOOKS LIKE THE GENERATOR WILL BE REMOVED SOMETIME THIS WEEK SO THE PATIENT CAN HAVE A THORACIC MRI PERFORMED. THIS IS ALL OF THE INFORMATION THAT REP HAD AT THIS TIME. MDR DECISION UPDATED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

    Description of Event or Problem · 0

    CALLER REPORTS PATIENT HAD A SPINAL FUSION DONE ABOUT 3 MONTHS AGO, PHYSICIAN THEN EXPLANTED BOTH LEADS, LEFT INS, CALLER REPORTS THAT WAS DONE AT A DIFFERENT FACILITY. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556534 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention "SEE H11....".