BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1871568 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17217
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1293-06 THRU Z1299-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT RECOMMENDED REPLACING THE DEVICE AS SOON AS POSSIBLE. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW PRODUCT ADVISORY POPULATION, DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER APPROXIMATELY 51 MONTHS OF IMPLANT. THE DEVICE REMAINS IMPLANTED AND IN SERVICE APPROXIMATELY TWO MONTHS AFTER ERI DECLARATION, WITH A CURRENT BATTERY MONITORING VOLTAGE OF 2.37 V AND A CHARGE TIME OF 22 SECONDS. THE POSSIBILITY OF PREMATURE BATTERY DEPLETION WAS DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR T125| 0184