BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1852625 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14250
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    May 21, 2010
    Report Date
    July 14, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 DEVICE WAS MANUFACTURED PRIOR TO THE MANUFACTURING CHANGES. THIS ISSUE IS DISCUSSED IN BOSTON SCIENTIFIC'S PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING THE EXPLANT PROCEDURE, THE PHYSICIAN OBSERVED THAT THE HEADER ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS LOOSE FROM THE CAN. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CLONMEL IRELAND 1870

    Patients

    Seq Age Sex Outcome Treatment
    1