BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2042421 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01266
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    November 11, 2010
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A SEPARATED HEADER. ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN CAUSING THE HEADER TO BECOME LOOSE, THE ROOT CAUSE OF THE ABNORMALITY WAS ISOLATED TO INSUFFICIENT BONDING BETWEEN THE MEDICAL ADHESIVE AND THE TITANIUM CASING. MANUFACTURING ENHANCEMENTS WERE IMPLEMENTED IN 2003 TO MAKE THE BOND MORE ROBUST.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THE CHANGE OUT PROCEDURE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FOUND TO HAVE A STUCK SETSCREW. THE LEFT VENTRICULAR (LV) SETSCREW WAS STUCK IN THE DOWN POSITION AND THE PHYSICIAN COULD NOT GET THE LV LEAD REMOVED FROM THE HEADER. THE SETSCREW WAS EVENTUALLY LOOSENED AND THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. ALL LEAD DIAGNOSTICS WERE NORMAL AND THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4512| N118| H135| 6947| 4479| H215