BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIENT

    MDR report key: 1951921 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23077
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE DELIVERED FIVE INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) LIKELY DUE TO A SUPRA-VENTRICULAR TACHYCARDIA. TACHYCARDIA THERAPY WAS EXHAUSTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED WHOM DISCUSSED DETECTION ENHANCEMENTS AND THERAPY DELIVERY. CURRENTLY, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR (B)(4)| (B)(4)| (B)(4)