BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2172817 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10263
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 AT THE POST-OPERATION CHECK FOLLOWING AN UPGRADE PROCEDURE, THE SHOCK IMPEDANCE MEASUREMENT WAS GREATER THAN 125 OHMS. A REVISION PROCEDURE WAS PERFORMED WHERE IT WAS NOTED THAT THE PROXIMAL PIN ON THE RIGHT VENTRICULAR (RV) LEAD WAS NOT ADEQUATELY SECURED INTO THE HEADER OF THE DEVICE. THE PHYSICIAN SECURED THE PIN PROPERLY, PLACED THE DEVICE BACK INTO THE POCKET AND REPEATED ALL TESTS. ALL MEASUREMENTS WERE SATISFACTORY AND THE DEVICE AND RV LEAD REMAIN IMPLANTED IN THE PATIENT. 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 66 YR Hospitalization| L| R E110| 0125| 1850| T175| 4135| 1740