BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2051869 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04849
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 18, 2011
    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

    THE SYSTEM REMAINS IMPLANTED. THE PHYSICIAN WAS CONTACTED IN AN ATTEMPT TO RETRIEVE FURTHER INFORMATION CONCERNING CLINICAL OUTCOMES. IT WAS REPORTED THE PHYSICIAN HAD ENCOUNTERED OTHER SIMILAR EVENTS. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IMPLANTED WITH NO FURTHER COMPLICATIONS. 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 DEVICE HAD BEEN IMPLANTED AND CONNECTED TO A CHRONIC COMPETITOR RIGHT VENTRICULAR (RV) LEAD. WIDE FLUCTUATIONS IN RV LEAD IMPEDANCE WERE MEASURED. NO OUT OF RANGE IMPEDANCE MEASUREMENTS WERE REPORTED. A REVISION PROCEDURE WAS PERFORMED AND THE SYSTEM WAS EVALUATED. NO LEAD PROBLEMS WERE NOTED DURING THE REVISION, AND THE SYSTEM REMAINED IMPLANTED. LATER, FURTHER IMPEDANCE FLUCTUATIONS WERE NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention