BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2905524 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-14004
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS DEVICE AND LEAD REMAIN IN SERVICE. 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 ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ALONG WITH NOISE. AN INVASIVE PROCEDURE WAS PERFORMED TO REVISE THE LEAD. WHEN THE POCKET WAS OPENED IT WAS NOTED THE RA LEAD WAS NOT FULLY INSERTED INTO THE DEVICE HEADER. THE LEAD WAS REINSERTED INTO THE DEVICE HEADER AND THE SET SCREWS WERE SECURED WHICH RESOLVED THE CLINICAL OBSERVATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11196 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4136| E110| 0184