BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1951347 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22778
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    October 15, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1678-09 TO Z-1679-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ICD WAS SUCCESSFULLY REPLACED, BUT WAS DISPOSED OF AT THE HOSPITAL, SO WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMAITON BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. THERE WERE NO ADDITIONAL PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1