BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 4132107 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14918
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS TRIGGERED DUE TO OUT OF RANGE PACING IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A REVIEW OF THE INFORMATION AND THE ARRHYTHMIA LOGBOOK NOTED MANY NON SUSTAINED VENTRICULAR TACHYCARDIA WITH NO THERAPY EVENTS SHORTLY AFTER THE IMPLANT. IN ADDITION NOISE WAS SEEN ON THE ELECTROCARDIOGRAMS. IT WAS ALSO NOTED THAT THE PATIENT RECEIVED A SHOCK BUT NO ALERT WAS TRIGGERED. TECHNICAL SERVICES EXPLAINED THAT THIS WOULD BE A YELLOW ALERT AND WOULD ONLY BE PICKED UP DURING A WEEKLY SWEEP OF THE DATA ON LATITUDE. A POSSIBLE CONNECTION ISSUE WAS SUSPECTED DUE TO THE NOISE SEEN. AT THIS TIME THE SYSTEM REMAINS IMPLANTED. ADDITIONAL INFORMATION RECEIVED NOTED THAT THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO BEING DEFECTIVE WHILE THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611395 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E160

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R E160| 0292