BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1863685 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15831
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REPORTEDLY PLANS TO IMPLANT A NEW SYSTEM ON THE PATIENT'S OPPOSITE SIDE, ONCE THE PATIENT'S CONDITION IMPROVES. A REQUEST HAS BEEN MADE TO HAVE THESE PRODUCTS RETURNED TO BOSTON SCIENTIFIC. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD, AND TRANSVENOUS LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED DUE TO A SYSTEM INFECTION. THE PATIENT'S COMPETITIVE RIGHT ATRIAL LEAD WAS ALSO EXPLANTED. THE POCKET WAS REPORTEDLY BEGINNING TO ERODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R 4548| 0185| H170| 5076