BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 2924934 · Received January 22, 2013

    Report

    Report Number
    2124215-2013-01485
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. NO ADDITIONAL INFORMATION CONCERNING THIS EVENT COULD BE OBTAINED THROUGH A COMPANY REPRESENTATIVE. WHILE THE PATIENT HAS CLAIMED THEIR DEVICE WAS REMOVED DUE TO THE INFECTION AND EROSION, ALL MEDICAL DEVICE TRACKING SYSTEMS STILL SHOW THE PATIENT'S DEVICE AS ACTIVE AND IMPLANTED. FOR NOW, THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29365 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R 0295| E140