BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2780579 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12832
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE PART OF A SYSTEM REVISION DUE TO INFECTION. THE LEADS ARE TEMPORARILY CAPPED AND WILL BE USED WITH THE NEW DEVICE POST INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R MISMATCH| 4097| 1851| 4244| 1871| 0145| F110