BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-18369

    MDR report key: 1871686 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18369
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WAS UNSUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A HEALTH CARE PROFESSIONAL (HCP) THAT THIS PATIENT EXPERIENCED SYNCOPE OF AN UNKNOWN ETIOLOGY AND AN FIELD REPRESENTATIVE WAS CONTACTED TO CHECK THE DEVICE. IT WAS UNKNOWN WHICH FIELD REPRESENTATIVE WAS CONTACTED AND NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVZ GUIDANT PUERTO RICO BV BRADY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening