BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3213222 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09518
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 6, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    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 LOOSE HEADER. ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN THE HEADER BECOMING LOOSE, THE 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. THE ENHANCEMENTS HAVE DECREASED REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED AN ABRUPT IMPEDANCE INCREASE OF GREATER THAN 500 OHMS AND INCREASED THRESHOLD MEASUREMENTS. NORMAL SHOCK IMPEDANCE AND SENSING WERE NOTED. NO ARRHYTHMIA EPISODES AND NO LOSS OF PACING WERE OBSERVED. A DECISION WAS MADE TO PERFORM A LEAD REVISION AND REMOVE A PREVIOUSLY SURGICALLY ABANDONED LEAD AND THE IMPLANTED RIGHT VENTRICULAR LEAD. DURING THE PROCEDURE, WHEN THE LEADS WERE BEING REMOVED, VISUAL OBSERVATION REVEALED THIS DEVICE HEADER WAS "WOBBLING". SOME FORCE WAS REQUIRED TO REMOVE THE DEVICE. IT WAS THOUGHT THE FORCE MAY HAVE CONTRIBUTED TO THE HEADER ISSUE. DURING THE LEAD REMOVAL, THE LEADS BROKE OFF. THE DEVICE AND LEADS WERE REPLACED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311976 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R