BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2911995 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00461
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD SUFFERED A SYNCOPAL EPISODE. THE PATIENT WAS DIRECTED TO CONTACT THEIR PHYSICIAN FOR FOLLOW-UP. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17543 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening 1860| E102| 1741| 0125