BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2163539 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07538
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, EXTERNAL VISUAL INSPECTION NOTED TOOL MARKS ON THE CASE AND BODY FLUID CONTAMINATION IN THE LEAD BARRELS AND SEAL PLUG CAVITIES. FURTHER VISUAL INSPECTION REVEALED THAT ALL SEAL PLUGS WERE INTACT AND ALL SET SCREWS OPERATED NORMALLY. IT WAS NOTED THAT THE HEADER ON THE DEVICE WAS LOOSE. X-RAY OF THE DEVICE HEADER FOUND THE RIGHT ATRIAL, RIGHT VENTRICULAR AND DEFIBRILLATION HEADER WIRES FRACTURED. A REVIEW OF THE DAILY MEASUREMENTS NOTED HIGH OUT OF RANGE SHOCKING AND ATRIAL IMPEDANCE MEASUREMENTS. ANALYSIS CONCLUDED THAT THE CAUSE OF THE HIGH IMPEDANCE MEASUREMENTS WAS BROKEN FEED THROUGH WIRES DUE TO A LOOSE HEADER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH SHOCK IMPEDANCE GREATER THAN 125 OHMS, SO A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION PROCEDURE THE BOSTON SCIENTIFIC SALES REPRESENTATIVE NOTED THAT THE SETSCREWS WERE FINE, HOWEVER THE HEADER ON THE DEVICE WAS LOOSE. IT WAS NOTED THAT THE DEVICE WAS IMPLANTED SUB PECTORAL. THE RV LEAD WAS TESTED WITH THE PACING SYSTEM ANALYZER AND PRODUCED ACCEPTABLE MEASUREMENTS. ONCE THE LEAD WAS RE-CONNECTED TO THE CHRONIC DEVICE, THE HIGH SHOCKING IMPEDANCE MEASUREMENTS PERSISTED. THE DEVICE WAS REPLACED AND WHEN THE CHRONIC RV LEAD WAS TESTED WITH THE NEW DEVICE, IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE. THE LEAD REMAINED IMPLANTED WITH THE NEW DEVICE. THIS DEVICE IS PART OF THE SUBPECTORAL IMPLANT 2009 PRODUCT ADVISORY THAT WAS INITIALLY COMMUNICATED ON (B)(6) 2009.

    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 Hospitalization| L| R 4469| 0175| E110