BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1951445 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22873
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION PROCEDURE, IT APPEARED THE TERMINAL PIN OF THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE LEAD PORT. LEAD VALUES MEASURED WITH A PACING SYSTEM ANALYZER WERE IN THE NORMAL RANGE. THE LEAD WAS RECONNECTED, AND ALL MEASUREMENTS WERE STABLE AND ACCEPTABLE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THE DEVICE REMAINS IMPLANTED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE HAD RECEIVED AN INAPPROPRIATE SHOCK DUE TO NOISE. NO PACING INHIBITION WAS NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A LATER REPORT WAS RECEIVED THAT THE DEVICE HAD DETECTED NOISE ON THE ATRIAL AND SHOCK CHANNELS. THE ATRIAL NOISE WAS OVERSENSED, LEADING TO MODE SWITCHING. 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 E110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention