BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1875161 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18463
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    --

    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 THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED SYNCOPE. THE CAUSE OF THE SYNCOPAL EPISODE WAS NOT REPORTED. AT THIS TIME, WE ARE UNABLE TO RULE OUT OUR PRODUCT INVOLVEMENT.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS DEVICE WAS INTERROGATED AND IT WAS DETERMINED THAT THE DEVICE WAS FUNCTIONING PROPERLY AND THERE WERE NO ARRHYTHMIC EVENTS RECORDED. HOWEVER, THE SOURCE OF THE SYNCOPE WAS NOT DETERMINED.

    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 83 YR Life Threatening (B)(4)| E110| 0184