BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3041273 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02360
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 18, 2012
    Report Date
    January 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1620-09 TO Z-1621-09
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS WERE VERIFIED DURING TESTING. THIS DEVICE IS INCLUDED IN THE (B)(4) 2007 SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A LONG CHARGE TIME OF 16.1 SECONDS ASSOCIATED WITH A BATTERY VOLTAGE OF 2.56, HOWEVER, THE CHARGE TIME REMAINED WITHIN THE EXTENDED CHARGE TIME LIMIT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED CONTINUED MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED SEVEN MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142871 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR T177| 0185