BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3043100 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01798
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PHYSICIAN

    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 DURING AN ATRIAL FLUTTER ABLATION PROCEDURE, WHILE IN ELECTROCAUTERY MODE, THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE CONTINUED TO INHIBIT PACING AND ASYSTOLE WAS OBSERVED FOR AN UNKNOWN PERIOD OF TIME. WHEN THE PROCEDURE WAS STOPPED, PACING RESUMED APPROPRIATELY IN THIS PACER DEPENDENT PATIENT. THE DEVICE WAS INTERROGATED FOLLOWING THE PROCEDURE AND WAS FOUND TO BE FUNCTIONING APPROPRIATELY. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145635 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening 4193| N140| 6949| 0292| 4076| (B)(4)