BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1950777 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22572
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD BEEN EMITTING BEEP TONES. IT WAS DETERMINED THAT THE DEVICE HAD DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) APPROXIMATELY 2 YEARS AGO. THE CURRENT MONITOR VOLTAGE WAS REPORTED TO BE 2.58 VOLTS WITH A CHARGE TIME OF 15.9 SECONDS. THERE WAS A DISCREPANCY IN THE VALUES AS THEY WERE GREATER THEN ERI. THE PATIENT WAS HAVING BREAST CANCER SURGERY AND THEY PLANNED TO REPLACE THE DEVICE SHORTLY AFTER THAT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AND THIS PRODUCT IS NOT LISTED ON ANY CURRENT PRODUCT ADVISORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR (B)(4)| (B)(4)| (B)(4)