BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2153411 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06265
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    January 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACING SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS HOSPITALIZED DUE TO SEPTIC SHOCK. THE INFECTION WAS TREATED WITH ANTIBIOTICS AND THE PACING SYSTEM REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE 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 75 YR Required Intervention (B)(4)| (B)(4)