BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1852176 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-16793
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS AVAILABLE. AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED A SYNCOPAL EPISODE. THE HEALTH CARE PROVIDER REQUESTED THE LOCAL FIELD REPRESENTATIVE BE PAGED TO CHECK THE PATIENT'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H217

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4457| 4136| 0185| H217| 1194| 4543