BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1852951 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14786
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT ASSOCIATED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPIRED. A SAVE TO DISK ANALYZED BY (B)(4) TECHNICAL SERVICES NOTED THAT THERE WERE NO INDICATIONS OF A DEVICE MALFUNCTION. THE SUSPECTED CAUSE OF DEATH WAS NOTED TO BE DUE TO SEPSIS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F111

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death 4096| 0293| F111