BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2042377 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01191
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-08 TO Z-0053-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED AN EPISODE OF SYNCOPE OF UNKNOWN CAUSE. IT WAS NOTED THAT THERE WERE NO VENTRICULAR TACHYCARDIA (VT) OR VENTRICULAR FIBRILLATION (VF) EPISODES IN THE ARRHYTHMIA LOGBOOK. IT WAS ALSO NOTED THAT THE DEVICE HAD REACHED END OF LIFE (EOL) DUE TO CHARGE TIME (CT), THUS IT WAS QUESTIONED IF THE EPISODE STORAGE WAS STILL AVAILABLE. TECHNICAL SERVICES (TS) DISCUSSED THE EPISODE STORAGE WAS STILL AVAILABLE. AT THIS TIME, ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening T177| 0157