BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 4232392 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19549
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS OF TODAY, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN THE HOSPITAL. THE DEVICE BEGAN TO AP-VP AT A RHYTHM OF 130-150 BEATS PER MINUTE. THE PATIENT DID NOT TOLERATE THE HIGH RATE PACING WELL. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND THE PATIENT WAS INTUBATED. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE SENT IN TELEMETRY STRIPS FOR TECHNICAL SERVICES TO REVIEW. OF NOTE, THERE WERE NO STORED EPISODES IN THE DEVICE'S EVENT LOGBOOK AND THE STRIPS THAT WERE SENT IN FOR REVIEW WERE DURING A PERIOD WHEN THE PATIENT WAS RECEIVING CPR. TS REVIEWED THE STRIPS AND SUSPECTED THAT VENTRICULAR RATE REGULATION (VRR) WAS THE SOURCE OF THE OBSERVED DEVICE BEHAVIOR. TS RECOMMENDED THAT A SAVE TO DISK BE SENT IN FOR REVIEW. THE FR PROGRAMMED RATE RESPONSE AND VRR TO OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FR. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715253 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R 4135| 4543| N140| 0292