BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 6025876 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-15890
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 28, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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'S 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A CHANGE OUT PROCEDURE FOR NORMAL BATTERY DEPLETION, THE PHYSICIAN WAS CONCERNED THAT THE PROXIMAL SETSCREW ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT ALL THE WAY TIGHTENED. IT WAS NOTED THAT THERE HAD BEEN NO CLINICAL OBSERVATIONS DURING THE TIME THE DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE DEVICE WAS EXPLANTED AS PLANNED. THE RIGHT VENTRICULAR (RV) LEAD REMAINED IMPLANTED WITH THE NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676720 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 0185| D141| T177