BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1873813 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17712
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A RED ALERT WAS DETECTED BY THE LATITUDE MONITORING SYSTEM FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS DISCOVERED THAT THE DEVICE HAD BEEN PROGRAMMED TO MONITOR ONLY FOR A SURGICAL PROCEDURE AND THERAPY WAS NOT REPROGRAMMED BACK ON AFTER THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS PATIENT WENT INTO THE CLINIC AND THEIR DEVICE WAS PROGRAMMED BACK ON. NO ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE DEVICE UNINTENTIONALLY BEING PROGRAMMED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR 0185| E102