BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1851774 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14201
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC CRM TECHNICAL SERVICE CONSULTANT REVIEWED THE EVENT AND DISCUSSED THAT THERE IS NO OTHER SOLUTION BUT TO TAKE THE DEVICE OUT. DEVICES IN SAFECORE CANNOT BE RESET. SAFECORE IS AN IMPORTANT SAFETY FEATURE THAT THE DEVICE ENTERS AFTER VARIOUS REDUNDANCY CHECKS THAT ARE NOT MATCHED. THERE MIGHT BE AN IMPACT FROM THE DEVICE BEING DROPPED OR EXTENSIVE ELECTROCAUTERY; HOWEVER, THIS CAN ONLY BE CONFIRMED THROUGH ANALYSIS TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE DEVICE REPLACEMENT PROCEDURE; THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN SAFECORE AND COULD NOT BE INTERROGATED. HOWEVER, DURING THE PROCEDURE THE DEVICE HAD FALLEN DOWN TO THE FLOOR AND PUT INTO A STERILIZER AND AFTER THE STERILIZATION. THE DEVICE WAS PLACED BACK INTO THE PATIENT. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICE CONSULTANT WAS CONTACTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other