BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1853489 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14456
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    May 19, 2010
    Report Date
    July 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THIS ISSUE IS DISCUSSED IN BOSTON SCIENTIFIC'S PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. UPON EXPLANT THE PHYSICIAN ADMITTED TO USING FORCE CAUSING THE HEADER TO POP BUT IT HAD NOT SEPARATED. 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 H170

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR A155| N119| H170| 0148| 4543| 4087