BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR IS-1/DF-1

    MDR report key: 1703133 · Received May 21, 2010

    Report

    Report Number
    2124215-2010-10018
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    April 7, 2010
    Report Date
    June 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. UPON COMPLETION OF ANALYSIS THIS REPORT WILL BE UPDATED. ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD A COMPROMISED LOW VOLTAGE CAPACITOR THAT DID NOT MEET DESIGN SPECIFICATION. DESPITE THIS COMPROMISED CAPACITOR, CURRENT LEAKAGE WAS NOT SUFFICIENT TO ADVERSELY IMPACT DEVICE LONGEVITY. ADDITIONALLY, THE MEMORY LOG WAS REVIEWED AND IT WAS DISCOVERED THAT THERE WAS A TIME WHEN THIS DEVICE DID NOT CAPTURE R-WAVE SIGNALS. IT WAS DETERMINED THAT THE DEVICE'S VENTRICULAR SENSITIVITY PARAMETER WAS SET AT LEAST SENSITIVITY. FROM THERE, THE LABORATORY TECHNICIAN CHANGED THE DEVICE'S SETTING TO NOMINAL AND THE DEVICE STARTED SENSING APPROPRIATELY. IT WAS CONFIRMED THAT THE DEVICE WAS CAPABLE OF DELIVERING BOTH BRADY AND TACHY THERAPIES AS PROGRAMMED. NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS WERE VERIFIED DURING TESTING. HENCE, THE FAILURE OF THE DEVICE TO SENSE R-WAVE WHILE IT WAS IMPLANTED COULD HAVE BEEN DUE TO IMPROPER SETUP OF THE SENSITIVITY PARAMETER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING OVERSENSING ON THE RIGHT VENTRICULAR (RV) CHANNEL. NO ASYSTOLE GREATER THAN 2 SECONDS WAS OBSERVED/REPORTED AND THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS EXPLANTED, REPLACED AND RETURNED FOR LABORATORY ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR