BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2920884 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01355
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    June 8, 2012
    Report Date
    February 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT A RED ALERT WAS STILL BEING INITIATED FROM THIS SYSTEM DUE TO SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE MEASUREMENTS WERE NOW BEING OBSERVED WITH THE LEAD CONFIGURED FROM VECTOR COIL TO CAN. ADDITIONALLY, PACING IMPEDANCE MEASUREMENTS HAVE INCREASED FROM 500 OHMS TO 1653 OHMS. A REVIEW OF THE ARRHYTHMIA LOGBOOK NOTED STORED EPISODES OF NOISE. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT EXPRESSED CONCERN ABOUT THE INTEGRITY OF THE LEAD DUE TO THE OUT OF RANGE SHOCK IMPEDANCE, INCREASED PACING IMPEDANCE AND NOISE. THERE WAS NOT ANY INAPPROPRIATE THERAPY DELIVERED FOR THE NOISE OR PAUSES IN PACING. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT ANOTHER LATITUDE RED ALERT WAS RECEIVED DUE TO PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS IN CONJUNCTION WITH THE RED ALERT FOR SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS. DAMAGE TO THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED DUE TO CLAVICULAR CRUSH. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS UNABLE TO BE EXTRACTED AS IT PULLED APART WITH TRACTION. A NEW LEAD WAS IMPLANTED WITHOUT FURTHER INCIDENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BROUGHT INTO THE CLINIC FOR DEFIBRILLATION THRESHOLD (DFT) TESTING WHICH WAS SUCCESSFUL AND THE PROXIMAL COIL WAS REMOVED FROM THE SHOCKING VECTOR. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THREE EPISODES OF SHORT BUT OBVIOUS NOISE WERE NOTED WITH THIS SYSTEM. THE BOSTON SCIENTIFIC REPRESENTATIVE COULD NOT REPRODUCE THE NOISE WITH ISOMETRICS AND THE PATIENT WAS UNAWARE OF ANY ISSUES. SUBSEQUENT INFORMATION WAS RECEIVED STATING THAT A LATITUDE RED ALERT WAS DETECTED DUE TO A SHOCKING IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. A REVIEW OF THE DAILY MEASUREMENTS NOTED PREVIOUS MEASUREMENTS WERE 60-70 OHMS WITH ONE OUT OF RANGE MEASUREMENT. THERE IS NO NOISE, AND NOTHING TO CORROBORATE A LEAD ISSUE. THE PATIENT WAS BROUGHT INTO THE CLINIC AND INITIAL TESTING IN TRIAD CONFIGURATION PRODUCED MEASUREMENTS GREATER THAN 125 OHMS. THE LEAD WAS NEXT TESTED RV TO CAN, WHICH PRODUCED MEASUREMENTS WITHIN NORMAL LIMITS. NEXT, RV TO RA WAS CONFIGURED AND AGAIN, MEASUREMENTS WERE GREATER 125 OHMS. LASTLY, NORMAL MEASUREMENTS WERE NOTED AGAIN RV TO CAN AND ALSO IN TRIAD. ONE MONTH LATER, ISOMETRICS WERE PERFORMED AND NORMAL MEASUREMENTS WERE OBTAINED. A RED ALERT WAS PRODUCED AGAIN AND THE PATIENT WAS BROUGHT IN FOR INTERROGATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26637 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR E102| 0185