BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3053573 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05039
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    October 10, 2012
    Report Date
    March 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. NO ADDITIONAL TESTING WAS PERFORMED AT THIS TIME. RECORDS INDICATE THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. REVIEW OF PREVIOUS DAILY MEASUREMENTS SHOWED SHOCK IMPEDANCE MEASUREMENTS IN THE 50 OHM RANGE. THE PATIENT WAS BROUGHT INTO CLINIC FOR FURTHER EVALUATION. IT WAS REPORTED THE PATIENT MAY HAVE BEEN AROUND AN ELECTROMAGNETIC INTERFERENCE (EMI) SOURCE AT THE TIME OF THE LOW OUT OF RANGE MEASUREMENT. IN CLINIC SHOCK IMPEDANCE MEASUREMENTS WERE 51-53 OHMS WHILE PERFORMING VARIOUS FORMS OF ISOMETRICS. THERE WAS NO EVIDENCE OF NOISE OR OVERSENSING ON THE LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED ADDITIONAL TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156487 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4470| E110| 0158