BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2162655 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07262
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED AN INFECTION AFTER THE IMPLANT OF THIS PRODUCT. REDNESS ACROSS THE ANTERIOR CHEST AND SCABBING AT THE LATERAL ASPECT OF THE INCISION WAS FIRST NOTED. THE PATIENT ALSO REPORTED ITCHING. THE PATIENT WAS GIVEN MEDICATION, HOWEVER THE REDNESS BECAME MORE SEVERE. THE MEDICATION WAS DISCONTINUED AND THE ITCHING AND REDNESS INVOLVED WITH THE INFECTION IMPROVED. THE PATIENT WAS DIAGNOSED HYPERSENSITIVE TO THE MEDICATION, AND TAKEN OFF ANTIBIOTICS. A CORTISONE CREAM WILL BE USED TO CONTROL THE INFECTION, WITH A FOLLOW-UP PLANNED IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R E110| 5076| 0158