BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT RC+S

    MDR report key: 20345007 · Received October 1, 2024

    Report

    Report Number
    2182207-2024-04059
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 1, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ACTIVA; PRODUCT ID 3389 (SERIAL: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE BRAND NAME ; PRODUCT ID 0913025. CITATION: AUTHORS: CARINA R. OEHRN,STEPHANIE CERNERA,LAUREN H. HAMMER,MARIA SHCHERBAKOVA,JIAANG YAO,AMELIA HAHN,SARAH WANG,JILL L. OSTREM,SIMON LITTLE,PHILIP A. STARR. CHRONIC ADAPTIVE DEEP BRAIN STIMULATION VERSUS CONVENTIONAL STIMULATION IN PARKINSON¿¿S DISEASE: A BLINDED RANDOMIZED FEASIBILITY TRIAL. NATURE MEDICINE 2024. DOI: 10.1038/S41591-024-03196-Z EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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

    LITERATURE WAS REVIEWED REGARDING CHRONIC ADAPTIVE DEEP BRAIN STIMULATION VERSUS CONVENTIONAL STIMULATION IN PARKINSON¿S DISEASE: A BLINDED RANDOMIZED FEASIBILITY TRIAL. THE FOLLOWING MEDTRONIC DEVICES WERE USED: B35300R MEDTRONIC SUMMIT RC+S, 3389 AND 0913025 LEADS. REPORTED EVENTS: PATIENT 2 EXPERIENCED A POSTOPERATIVE UNILATERAL HARDWARE INFECTION THAT REQUIRED SURGICAL REMOVAL. A NEW DEVICE WAS IMPLANTED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41079 SUMMIT RC+S STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION B35300R

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention SEE H11...