BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 20219390 · Received September 14, 2024

    Report

    Report Number
    2182207-2024-03881
    Event Type
    Injury
    Date Received
    September 14, 2024
    Report Date
    March 16, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: VALLEJO R, FISHMAN MA, SHAH B, ET AL. TARGETED NERVE ROOT STIMULATION ALLEVIATES INTRACTABLE CHRONIC LIMB PAIN ASSOCIATED WITH COMPLEX REGIONAL PAIN SYNDROME - A PROSPECTIVE MULTI-CENTER FEASIBILITY STUDY. PAIN PHYSICIAN. 27(4):213-222. A2: PLEASE NOTE THAT THIS FIELD REPRESENTS THE AVERAGE AGE OF STUDY PARTICIPANTS. A3B: PLEASE NOTE THAT THIS FIELD REPRESENTS THE GENDER OF THE MAJORITY OF STUDY PARTICIPANTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A2 PRODUCT TYPE LEAD, UBD: ASKU, UDI#: ASKU 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THE EVENT CONTAINED IN THIS REPORT HAS BEEN PREVIOUSLY REPORTED THROUGH REGULATORY REPORT #3004209178-2022-05883. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS INCIDENT WILL BE SUBMITTED AS PART OF THAT RECORD.

    Description of Event or Problem · 0

    ONE PATIENT EXPERIENCED LEAD MIGRATION THAT REQUIRED A SURGICAL REVISION. THE ¿LEAD MOVEMENT REDUCED THERAPEUTIC EFFECT IN THE PATIENT.¿ IT WAS NOTED THE REVISION COULD NOT BE SCHEDULED TIMELY DUE TO COVID-19 RESTRICTIONS AT THE TIME. PLEASE FIND THE LITERATURE ARTICLE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101652 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 97715 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Required Intervention