BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2012-11397

    MDR report key: 2778598 · Received October 9, 2012

    Report

    Report Number
    2124215-2012-11397
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 17, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT INFORMED THE CALLER THAT THIS DEVICE DOES NOT HAVE THAT FEATURE. THE CONSULTANT DISCUSSED OTHER PROGRAMMING OPTIONS FOR THIS PATIENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED SOME SYNCOPAL EPISODES. THE CALLER WAS INQUIRING ABOUT THE SUDDEN BRADY RESPONSE (SBR) FEATURE FOR THIS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening 4136| S601