BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION SYSTEM

    MDR report key: 17720847 · Received September 8, 2023

    Report

    Report Number
    MW5145474
    Event Type
    Injury
    Date Received
    September 8, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE CALLER REPORTED THAT THE PATIENT'S STIMULATOR SUDDENLY STARTED GOING DEAD A COUPLE OF DAYS AFTER THEY CHARGED IT, THEN THEY STARTED HAVING TREMORS AGAIN. THE CALLER SAID THEY WERE TOLD TO CALL (B)(6) BEFORE SEEING THE PATIENT'S DOCTOR, BUT WHEN THEY CALLED (B)(6) HER VOICEMAIL GREETING ADVISED THE CALLER TO CALL PATIENT SERVICES. AGENT WAS UNABLE TO LOCATE THE PATIENT'S DEVICE IN THE SYSTEM, AT WHICH POINT IT WAS REVEALED THAT THE PATIENT HAS A BOSTON SCIENTIFIC DBS SYSTEM. AGENT PROVIDED THE CALLER WITH THE PHONE NUMBER FOR BOSTON SCIENTIFIC (833-327-4636) AND ATTEMPTED TO WARM TRANSFER THE CALLER TO BOSTON SCIENTIFIC, BUT THE CALLER DISCONNECTED. AGENT CALLED THE CALLER BACK, BUT THEY DID NOT ANSWER. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062755 DEEP BRAIN STIMULATION SYSTEM STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown