BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904757 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10866
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD PACE IMPEDANCES MEASURING GREATER THAN 2,000 OHMS. SUBSEQUENTLY, THIS PATIENT UNDERWENT INTERVENTION AND THE LEAD WAS EXPLANTED AND REPLACED. NO LEAD FRACTURE WAS OBSERVED; HOWEVER, THERE WAS A VISUAL LEAD ABRASION. THE LEAD REMAINS AT THE HOSPITAL AT THIS TIME FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382229 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R 0292| F110| 4473| 0181| F162