BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2153557 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06366
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    September 6, 2010
    Report Date
    April 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D WAS DISCARDED AT THE HOSPITAL. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED A ASEPTIC DECUBITUS WHERE THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS IMPLANTED. THE DECISION WAS MADE TO CLEAN THE POCKET OUT, AND IMPLANT A NEW DEVICE IN A NEW SUBPECTORAL POCKET. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1