BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE DEVICE

    MDR report key: 11263639 · Received February 1, 2021

    Report

    Report Number
    2124215-2021-02419
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    November 13, 2020
    Report Date
    February 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT EXPERIENCED SYNCOPE AND HIT THEIR HEAD AS A RESULT. THE PATIENT WAS REFERRED TO THEIR PHYSICIAN, BUT WAS REDIRECTED TO PERFORM A PATIENT INITIATED INTERROGATION (PII). A PII WAS SUCCESSFULLY PERFORMED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153896 IMPLANTABLE DEVICE DXY BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other