BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 24653045 · Received March 20, 2026

    Report

    Report Number
    3004209178-2026-05068
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    January 23, 2026
    Report Date
    March 20, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO JUNCOS
    Product Code
    LGW
    UDI-DI
    00613994188724
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 377660 LOT# V021032. IMPLANTED: (B)(6) 2007. EXPLANTED: (B)(6) 2019. PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377660, SERIAL/LOT #: (B)(6), UBD: 05-FEB-2011, 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 (PT) REPORTED THAT IN THE PAST, REPLACING THE WIRES WAS PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711510 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO JUNCOS 37713 00613994188724

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention "SEE H11....".