BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 4140387 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17034
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED PRODUCTS ARE NOT EXPECTED TO BE RETURNED. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED INFLAMMATION AND BURNING OF THE DEVICE POCKET. THE PATIENT WAS SEEN ONE MONTH LATER DURING A FOLLOW UP VISIT WHERE IT WAS DISCOVERED THAT THE ICD WAS ERODING THROUGH THE POCKET. A REVISION WAS PERFORMED AND THE SYSTEM WAS EXPLANTED. THE PATIENT REMAINS HOSPITALIZED WITH ANTIBIOTICS BEING ADMINISTERED AND THE LEADS WERE SENT FOR CULTURES FOR INFECTION EVALUATION. A NEW ICD SYSTEM WILL BE IMPLANTED AT A LATER DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WERE NO ALLEGATIONS AGAINST ANY OF THE IMPLANTED PRODUCTS. THE PHYSICIAN FEELS THAT THE POCKET EROSION WAS RELATED TO THE CONDITION OF THE PATIENT'S SKIN AND WHEN THE NEXT DEVICE IS IMPLANTED, THE PHYSICIAN IS PLANNING ON A SUBPECTORAL PLACEMENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618632 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R E142| 4136| 0296