BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3210155 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07473
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM EXPERIENCED DIZZINESS. INTERROGATION OF THE DEVICE REVEALED NOISE WITH OVERSENSING ON THE RV LEAD OF THIS PACEMAKER DEPENDENT PATIENT. HOWEVER, THERE WAS NO ASYSTOLE GREATER THAN TWO SECONDS. THE NOISE ON THE RV CHANNEL WAS REPRODUCED WITH THE VALSALVA MANEUVER. WHEN ISOMETRICS WERE PERFORMED NOISE WAS ONLY NOTED ON THE SHOCK ELECTROGRAM (EGM). RV SENSITIVITY WAS DECREASED WITH APPARENT RESOLUTION OF THE ISSUE. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED CONSIDERATION OF DEFIBRILLATION THRESHOLD (DFT) TESTING TO ASSESS SENSING OF VENTRICULAR FIBRILLATION (VF). THE FIELD REPRESENTATIVE REVIEWED THE INFORMATION WITH THE PHYSICIAN AND, AT THIS TIME, THERE WERE NO PLANS FOR DFT TESTING AND THE PATIENT WILL BE MONITORED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE NOISE AND OVERSENSING CONTINUED AND RESULTED IN GREATER THAN TWO SECONDS OF ASYSTOLE, AND THE PATIENT AGAIN, REPORTED EPISODES OF DIZZINESS. THE NOISE WAS REPRODUCIBLE WITH ARM MOVEMENTS. FURTHER REPROGRAMMING WAS DONE AND THE RV SENSITIVITY WAS CHANGED TO THE LEAST SENSITIVE SETTING. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310589 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R 4543| 4087| N140| 0295| 4542