BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1861088 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15382
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 29, 2010
    Report Date
    June 16, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE DEVICE WAS REPROGRAMMED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION IN AUGUST 2010 THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO AGAIN REVIEW AN EPISODE FROM A LATITUDE REPORT. THIS EPSIODE OCCURRED BACK IN (B)(6) 2010 AND HAD BEEN REVIEWED AT THAT TIME. TECHNICAL SERVICES REVIEWED THE EPSIODE, PROVIDED AN EXPLANATION ON WHY THE DEVICE DELIVERED THERAPY AND RECOMMENDED PROGRAMMING OPTIONS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REQUEST AN EPISODE EVALUATION. THE PATIENT SPONTANEOUSLY DEVELOPED SUPRAVENTRICULAR TACHYCARDIA (SVT) WHICH WAS TREATED WITH ANTITACHYCARDIA PACING (ATP) AND SHOCK THERAPY. THE RATE OF THE ARRHYTHMIA REMAINED UNCHANGED FOLLOWING THERAPY EXHAUSTION. UPON EPISODE REVIEW, THE ATRIAL AND VENTRICULAR RATE WAS 1:1 AND THERAPY WAS NOT INHIBITED. THEREFORE, THE ARRHYTHMIA WAS CATEGORIZED (RHYTHM ID) AS "UNCORRELATED" AND THERAPY WAS DELIVERED. THE LOCAL REPRESENTATIVE WAS PLANNING TO DISCUSS THIS FURTHER WITH THE PHYSICIAN.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORTORY ON (B)(6) 2016. THE DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 1861| 4470| T167