BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 24990946 · Received April 24, 2026

    Report

    Report Number
    3006630150-2026-02624
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATION, THE PATIENT FELL BETWEEN (B)(6), 2026. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2202-45, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7140679, MODEL/CATALOG DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 45CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICES REMAIN IMPLANTED IN THE PATIENT; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AND STATES THAT FAILURE OR MALFUNCTION OF ANY PART OF THE DEVICE, INCLUDING BUT NOT LIMITED TO: BATTERY LEAKAGE, BATTERY FAILURE, LEAD OR LEAD EXTENSION BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS, AND LEAD INSULATION BREACHES, WHETHER OR NOT THESE PROBLEMS REQUIRE DEVICE REMOVAL AND/OR REPLACEMENT, WEAKNESS, MUSCLE SPASMS, SHAKING, RESTLESSNESS, OR PROBLEMS WITH MOVEMENT, IMPLANTED DEVICE COMPONENTS (STIMULATOR, LEAD, OR LEAD EXTENSION) MAY MOVE FROM ORIGINAL IMPLANTED LOCATION OR WEAR THROUGH THE SKIN, WHICH MAY LEAD TO THE NEED FOR ADDITIONAL SURGERY, GAIT DIFFICULTY (TROUBLE WALKING) AND FALLS, AND LOSS OF ADEQUATE STIMULATION ARE A KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A FALL AFTER THE DBS IMPLANT PROCEDURE BUT PRIOR TO INITIAL PROGRAMMING AND FIRST ACTIVATION OF THE DEVICE. THE FALL CAUSED THE IMPLANTABLE PULSE GENERATOR (IPG) TO FLIP UPSIDE DOWN IN THE POCKET, RESULTING IN THE INABILITY TO CHARGE THE IPG. THE PHYSICIAN WAS ABLE TO MANUALLY MANIPULATE THE IPG TO FLIP BACK TO PLACE, AND CHARGING FUNCTIONALITY HAS SINCE BEEN RESTORED. ADDITIONALLY, DUE TO THE FALL, THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) SCAN TO ASSESS THE HIP. PRIOR TO THE VISIT, THE PATIENT HAD REPORTED CONCERNS REGARDING BALANCE AND GAIT. FOLLOWING PROGRAMMING, THE PATIENT DEMONSTRATED SIGNIFICANT IMPROVEMENT IN TREMORS AND SPIRAL TESTING DURING EXAMINATION. THE DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568426 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 807023 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention