BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2171073 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10105
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 8, 2011
    Report Date
    September 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, INFORMATION WAS RECEIVED THAT THIS DEVICE WAS REMOVED FROM SERVICE FOR REASON OF NORMAL BATTERY DEPLETION. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THE SURGICAL PROCEDURE. THIS DEVICE HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC. THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY AND INITIALLY COMMUNICATED ON (B)(6) 2007, REACHED A MONITORING VOLTAGE MEASUREMENT OF 2.55 VOLTS AND A CHARGE TIME MEASUREMENT OF 18.4 SECONDS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT WAS UNABLE TO PROVIDE A LONGEVITY ESTIMATE DUE TO THE EXTENDED CHARGE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR (B)(4)| (B)(4)