BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCEPT

    MDR report key: 23425683 · Received October 30, 2025

    Report

    Report Number
    3004209178-2025-18508
    Event Type
    Death
    Date Received
    October 30, 2025
    Date of Event
    September 13, 2025
    Report Date
    October 30, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000813543
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: B3300542M, SERIAL/LOT #: (B)(6), UBD: 14-MAR-2027, 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

    IT WAS REPORTED THAT THE PATIENT WAS FOUND UNCONSCIOUS AT THEIR HOME AND RUSHED TO THE EMERGENCY DEPARTMENT. A BRAIN CT SCAN REVEALED A LARGE LEFT SIDED EPIDURAL HEMATOMA. A LEFT SIDE CRANIOTOMY WAS PERFORMED AND EVACUATION OF AN EPIDURAL HEMATOMA WAS PERFORMED. IT WAS ALSO NOTED THAT THERE WAS A SUBDURAL HEMATOMA, CRITICAL MASS EFFECT AND MIDLINE SHIFT. THE PATIENT WAS TRANSFERRED TO THE STEPDOWN ICU AND RECEIVED PALLIATIVE CARE. THE PATIENT PASSED AWAY ON (B)(6) 2025. THE ETIOLOGY WAS LISTED AS NOT RELATED TO THE IMPLANT PROCEDURE, POSSIBLY RELATED TO THE DEVICE/THERAPY, AND SECONDARY TO A FALL. ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE EVENT ETIOLOGY OF PROGRAMMING/STIMULATION COULD NOT BE EXCLUDED. HOWEVER, MAIN ETIOLOGY SHOULD BE TRAUMATIC BRAIN INJURY SECONDARY TO FALL, AS DOCUMENTED. IT WAS REPORTED THAT THE EVENT INFORMATION OF THE FALL "RESULTING IN LARGE LEFT SDH WITH CRITICAL MASS EFFECT AND MIDLINE SHIFT. LEFT SIDE CRANIOTOMY AND EVACUATION OF EDH ON (B)(6) 2025" WAS REMOVED, HOWEVER, IT REMAINS ELSEWHERE IN THE CLINICAL REPORT SO IT IS UNKNOWN IF THIS REMAINS RELATED. THE ETIOLOGY WAS UPDATED TO INCLUDE THAT THE ISSUE WAS RELATED TO PROGRAMMING, WHICH THE MOST RECENT PROGRAMMING CHANGE WAS ON (B)(6) 2025. DEVICE INFORMATION RECEIVED. IT WAS REPORTED THAT IT WAS UNKNOWN IF THE DEVICE, THERAPY, OR A NUANCE UNIQUE TO THE DEVICE PROCEDURE CAUSAL OR CONTRIBUTORY WITH RESPECT TO THE SYMPTOMS. THERE WAS NO CHANGE IN THERAPY, AND NO PRIOR SIGNS, PRIOR TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297221 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35300 00763000813543

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Required Intervention| D| L| H SEE H11.