BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2780939 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13008
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 1, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION FOUND THAT THE ANCHOR POSTS FOR ATTACHING THE HEADER WERE BENT. BASED ON THE BENT ANCHOR POST IT APPEARED EXCESSIVE FORCE WAS USED DURING THE EXPLANT PROCEDURE. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PATIENT WITH THIS DEVICE WAS SEEN FOR A ROUTINE PULSE GENERATOR CHANGE OUT PROCEDURE. UPON REMOVING THE DEVICE FROM THE POCKET, IT WAS NOTED THAT THE FRONT OF THE HEADER WAS LOOSE. THE BACK OF THE HEADER WAS STABLE. ALL DEVICE DIAGNOSTICS DURING PRE-PROCEDURE INTERROGATION WERE NOTED TO HAVE BEEN NORMAL. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE IS TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 6947| T175