BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1852676 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14253
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE LEAD WILL NOT BE RETURNED, HOWEVER THE DEVICE WOULD BE COMING BACK. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND DEFIBRILLATION LEAD WERE EXPLANTED DUE TO A PATIENT INFECTION. IT WAS ALSO REPORTED THAT THIS PATIENT HAD OTHER HEALTH ISSUES AND THE INFECTION WAS NOT DEVICE RELATED NOR THOUGHT TO BE COMING FROM THE POCKET. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. A NEW DEVICE MIGHT BE IMPLANTED AFTER THE PATIENT HAS A CHANCE TO HEAL. THE PATIENT HAS BEEN PLACED IN A DEFIBRILLATION VEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 0175| E102