BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2780942 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13289
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2012
    Report Date
    March 23, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    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

    SUBSEQUENT INFORMATION INDICATES THAT THE SYSTEM DISPLAYED A HIGH, OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WITH THE LAST YEAR. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE PATIENT WAS SEEN FOR FOLLOW. A 21 JOULE SHOCK WAS DELIVERED INTO THE SYSTEM WITH RESULTING NORMAL SHOCK IMPEDANCE MEASUREMENTS. THE SYSTEM WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE.

    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 55 YR Life Threatening| R E110| 1851| 1488T| 0127| T127