BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2040095 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00776
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 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

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED END OF LIFE (EOL) DUE TO CHARGE TIME (CT). IT WAS NOTED THAT A MANUAL CAPACITOR REFORMATION WAS DONE WHICH RESULTED IN A FAULT CODE (FC) 01. THE FC WAS QUESTIONED. TECHNICAL SERVICES (TS) DISCUSSED THE FC WAS DUE TO A CT GREATER THAN 45 SECONDS, AND RECOMMENDED THAT THE DEVICE BE REPLACED. IT WAS NOTED THAT THE DEVICE WAS SCHEDULED TO BE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR (B)(4)| MISMATCH| 0184