BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3040736 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03114
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A SYNCOPAL EPISODE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED AT THE TIME OF THE CALL. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT TO THE LOCAL FIELD REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144041 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R 0184| 4086| T165| E110