BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1771231 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12211
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    May 31, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE DEVICE HAS BEEN REMOVED, REPLACED AND RETURNED, ANALYSIS WILL BE PERFORMED IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    AS THE DEVICE HAS NOT BEEN RETURNED, BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE DISPLAYED END OF LIFE (EOL) BATTERY STATUS DUE TO EXTENDED CHARGING TIME. THE PATIENT WAS SCHEDULED FOR A DEVICE REPLACEMENT PROCEDURE, HOWEVER THE PATIENT REFUSED IMMEDIATE REPLACEMENT AND WILL SCHEDULE IN THE NEAR FUTURE. THE SENSING AND IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL VALUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. REPORTEDLY, THE PATIENT WITH THIS DEVICE DID NOT RETURN FOR THEIR FOLLOW UP VISIT. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1871

    Patients

    Seq Age Sex Outcome Treatment
    1