BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 4232379 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19536
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DAY AFTER A DEVICE CHANGE-OUT AND AV NODE ABLATION A NURSE CLINICIAN WAS DOING PREDISCHARGE TESTING. REPORTEDLY THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD CAPTURE TESTS WERE DONE WITHOUT ISSUE. HOWEVER, WHILE DOING THE LEFT VENTRICULAR (LV) LEAD CAPTURE THRESHOLD TEST, THE SCREEN FROZE AND THE CLINICIAN WAS UNABLE TO STOP THE TEST. THE CLINICIAN DID NOT NOTICE ANY TELEMETRY LIGHTS, DROP-OUTS, OR DIALOG BOXES. THE END TEST BUTTON WAS PUSHED, AND WHEN THE TEST CONTINUED IT WAS PUSHED AGAIN SEVERAL TIMES. THE PATIENT HAD A SYNCOPAL EVENT WHEN CAPTURE WAS LOST. THE CLINICIAN WAS USING THE WAND ONLY, AND THE MICS ANTENNA WAS NOT CONNECTED. THE PROGRAMMER WAS BEING RETURNED. THE DEVICE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714662 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening 5076| N141| 0181| MISMATCH