BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2171585 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09851
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY (B)(6) LATER WE RECEIVED INFORMATION THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHICH WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON (B)(6) 2007, DECLARED END OF LIFE (EOL) DUE TO A GREATER THAN 30 SECOND CHARGE TIME MEASUREMENT. THE MONITORING VOLTAGE WAS 2.57 VOLTS. A DEVICE REPLACEMENT PROCEDURE HAD BEEN SCHEDULED FOR A DATE IT EH NEAR FUTURE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 65 YR Life Threatening| R (B)(4)| (B)(4)| (B)(4)