BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1852758 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14665
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 PARTIALLY SEPRATED HEADER. EXAMINATION OF THE DEVICE REVEALED DAMAGE TO THE PORTION OF THE MOLDED HEADER WHICH SURROUNDS THE DF+ SIDE MOUNTING POST. 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. THE DEVICE WAS SUBMITTED FOR THERAPY VERIFICATION TESTING. THERAPY VERIFICATION TESTING PRODUCED NO TEST FAILURES. AT THE TIME OF EXPLANT THE DEVICE WAS CAPABLE OF PROVIDING THERAPY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ELECTIVELY EXPLANTED FOR AN UPGRADE TO A COMPETITOR'S CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR. THE ICD HAD BEEN IMPLANTED SUBCUTANEOUSLY. IT WAS REPORTED THAT THE DEVICE WAS REMOVED WITHOUT ANY EXCESS FORCE. EVERYTHING APPEARED TO BE INTACT AFTER THE DEVICE WAS REMOVED. THE ELECTROPHYSIOLOGY LAB MANAGER APPLIED SOME PRESSURE TO THE DEVICE HEADER WITH THEIR THUMB AND FOREFINGER RESULTING IN THE LOOSENING OF THE HEADER. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE WHILE IT WAS IN SERVICE. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR MISMATCH| 4470| T125| 0185