BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1881339 · Received October 25, 2010

    Report

    Report Number
    2124215-2010-18068
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, MICROSCOPIC INSPECTION NOTED THAT A LEAD TERMINAL PIN (1/2) WAS RETURNED IN THE ATRIAL LEAD BARREL. THE LEAD PIN WAS REMOVED WITHOUT DIFFICULTIES. THE DF+ SETSCREW WAS STUCK IN THE UP POSITION AND THE RETAINER RING WAS BENT UPWARD. THE FORCE REQUIRED TO FREE THIS SETSCREW WAS MEASURED TO BE 21 IN-OZ'S. ALL OTHER SETSCREWS MOVED FREELY. THE DEVICE PASSED ELECTRICAL TESTING. ANALYSIS CONCLUDED THAT THE DAMAGE TO THE LEAD AND STUCK DF+ SETSCREW WAS CONSISTENT WITH INDUCED DAMAGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING THE DEVICE CHANGE OUT PROCEDURE OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE PHYSICIAN UNSCREWED THE SET SCREWS FOR THE ATRIAL LEAD. HE THEN APPLIED GENTLE TRACTION TO REMOVE THE LEAD FROM THE HEADER AND THE TERMINAL PIN BECAME SEPARATED FROM THE LEAD BODY AND REMAINED IN THE HEADER. IT WAS NOTED THAT THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION, SO THE ATRIAL LEAD WAS SURGICALLY ABANDONED AND THE ATRIAL PORT OF THE NEW DEVICE WAS PLUGGED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)