BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERCISE GENUS

    MDR report key: 18681970 · Received February 9, 2024

    Report

    Report Number
    3006630150-2024-00609
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DATABASE ANALYSIS PERFORMED IDENTIFIED A BLUETOOTH FAULT CODE WHEN CHARGING THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) BATTERY. NOISE FROM THE CHARGING FIELD OF THE CHARGER INTERFERES WITH THE BLUETOOTH COMMUNICATION CHIPSET, THUS CAUSING INTERNAL RESETS WHERE THE DEVICE STIMULATION MOMENTARILY TURNS OFF AND THEN RETURNS TO NORMAL OPERATION. NO OTHER ANOMALIES WERE FOUND WITH THE ANALYSIS AS THE DEVICE DISPLAYED A NORMAL CHARGE LOG. THE IPG REMAINS IMPLANTED IN THE PATIENT AND DELIVERING THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DATABASE ANALYSIS PERFORMED IDENTIFIED A BLUETOOTH FAULT CODE WHEN CHARGING THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) BATTERY. NOISE FROM THE CHARGING FIELD OF THE CHARGER INTERFERES WITH THE BLUETOOTH COMMUNICATION CHIPSET, THUS CAUSING INTERNAL RESETS WHERE THE DEVICE STIMULATION MOMENTARILY TURNS OFF AND THEN RETURNS TO NORMAL OPERATION. NO OTHER ANOMALIES WERE FOUND WITH THE ANALYSIS AS THE DEVICE DISPLAYED A NORMAL CHARGE LOG. 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 9028509-101-00. REFERENCE PMA APPROVAL P150031. THE PATIENT IS ABLE TO SUCCESSFULLY CHARGE THE IPG WITHOUT INTERRUPTION. NO FURTHER ACTION RELATED TO THIS EVENT IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51414 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 529846 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female