BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3904252 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09759
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 4, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THREE DAYS POST IMPLANT OF THIS DEVICE, THIS PATIENT PRESENTED TO THE EMERGENCY ROOM WITH POSTOPERATIVE HEMORRHAGE, HYPOTENSION, HYPOVOLEMIA WITH SUBSEQUENT ACUTE RENAL INSUFFICIENCY, REACTIVE LEUKOCYTOSIS AND ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE ISSUES WERE ALL RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384919 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R E142| 0292| 4086