BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1945589 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19831
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 8, 2010
    Report Date
    October 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A PATIENT ADVOCATE THAT THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) WAS NOT WORKING. THE ADVOCATE STATED THAT THE PATIENT'S HEART RATE WAS TOO HIGH AND THE PATIENT WAS IN THE HOSPITAL. A BSC FIELD REPRESENTATIVE (FR) WAS TO BE PAGED TO INTERROGATE THE DEVICE. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION HAS BEEN MADE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR H115| H219| 4469| 0157| 4512