BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2010-20330

    MDR report key: 1946175 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20330
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT IDENTIFYING INFORMATION WE ARE UNABLE TO FOLLOW UP FOR ADDITIONAL INFORMATION AND RESOLUTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED A YELLOW WARNING SCREEN UPON INTERROGATION. THE HEALTH CARE PROFESSIONAL REFUSED TO PROVIDE PATIENT NAME AND/OR MODEL-SERIAL NUMBER OF THE DEVICE IN QUESTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1