BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERCISE GENUS

    MDR report key: 18145303 · Received November 15, 2023

    Report

    Report Number
    3006630150-2023-07062
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 28, 2022
    Report Date
    April 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985051
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN BLOCK B5 BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EVENT OCCURRED IN OCTOBER 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION, AN UNDESIRED SENSATION, AND A RETURN OF HIS TREMORS WHEN CHARGING THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE DATABASE ANALYSIS PERFORMED IDENTIFIED A BLUETOOTH FAULT CODE WHEN CHARGING THE IPG. NOISE FROM THE CHARGING FIELD OF THE CHARGER INTERFERES WITH THE BLUETOOTH COMMUNICATION CHIPSET, THUS CAUSING INTERNAL RESETS WHERE THE DEVICE STIMULATION TURNS OFF FOR 10-15 SECONDS AND THEN RETURNS TO NORMAL OPERATION. NO OTHER ANOMALIES WERE FOUND WITH THE ANALYSIS AS THE DEVICE DISPLAYED A NORMAL CHARGE LOG AND ALL IMPEDANCES WERE WITHIN THE EXPECTED RANGE. THE IPG REMAINS IMPLANTED IN THE PATIENT AND DELIVERING THERAPY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT A BOSTON SCIENTIFIC REPRESENTATIVE, IN CONSULTATION WITH THE TREATING CLINICIAN, PERFORMED AN IPG FIRMWARE UPDATE THAT HAS RESOLVED THE BLUETOOTH FAULT CODE ERROR WHEN CHARGING THE IPG. THE APPLICABLE FIRMWARE IS MODEL 9028506-103-00. REFERENCE PMA APPROVAL P150031. THE PATIENT IS ABLE TO SUCCESSFULLY CHARGE THE IPG WITHOUT INTERRUPTION. NO FURTHER ACTION RELATED TO THIS EVENT IS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION, AN UNDESIRED SENSATION, AND A RETURN OF HIS TREMORS WHEN CHARGING THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE DATABASE ANALYSIS PERFORMED IDENTIFIED A BLUETOOTH FAULT CODE WHEN CHARGING THE IPG. NOISE FROM THE CHARGING FIELD OF THE CHARGER INTERFERES WITH THE BLUETOOTH COMMUNICATION CHIPSET, THUS CAUSING INTERNAL RESETS WHERE THE DEVICE STIMULATION TURNS OFF FOR 10-15 SECONDS AND THEN RETURNS TO NORMAL OPERATION. NO OTHER ANOMALIES WERE FOUND WITH THE ANALYSIS AS THE DEVICE DISPLAYED A NORMAL CHARGE LOG AND ALL IMPEDANCES WERE WITHIN THE EXPECTED RANGE. THE IPG REMAINS IMPLANTED IN THE PATIENT AND DELIVERING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161722 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1232 517847 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male