BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2153585 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06529
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    August 16, 2005
    Report Date
    April 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD AN INFECTION AT THE INCISION SITE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND AFTER 5 DAYS A FOLLOW-UP VISIT SHOWED THE SITE WAS HEALING WELL. THERE WAS NO FURTHER EVIDENCE OF INFECTION. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H155

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 4403| 4517| 0148| H155| 7304| 4087