BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1945760 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20369
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REPORTED FEELING DIZZY AND STRESSED OUT. ALSO MENTIONED THAT IN THE EVENING THEY AWOKE AND WERE UNSURE IF THEY PASSED OUT OR NOT. THE PATIENT WAS CONCERNED THAT THE DEVICE PROGRAMMING COULD HAVE BEEN ALTERED DUE TO AIRPORT WAND PLACEMENT OVER THE DEVICE. TECHNICAL SERVICES (TS) DISCUSSED MAGNETIC INTERFERING AND ITS AFFECTS ON THE DEVICE. IT IS UNKNOWN WHETHER OR NOT THIS PATIENT TRULY EXPERIENCED A SYNCOPAL EPISODE AND WHETHER OR NOT IT WAS RELATED TO THE FUNCTIONALITY OF OUR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening E110| 0174| 4087