BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3232021 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11207
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE CONFIRMED THAT THE HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS WERE A KNOWN ISSUE FOR THIS PATIENT AND THE CLINIC WAS CONTINUING TO MONITOR THE ISSUE WITH INCREASED REMOTE FOLLOW-UPS. THE DEVICE AND THE COMPETITIVE RV LEAD REMAIN IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED COMPETITIVE RIGHT VENTRICULAR (RV) LEAD RECORDED A HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. A RED ALERT WAS ISSUED IN THE PATIENT'S REMOTE MONITORING SYSTEM DUE TO THE OUT-OF-RANGE MEASUREMENT. IT WAS NOTED THAT THE PATIENT HAD UNDERGONE AN ABLATION PROCEDURE ABOUT 12 DAYS BEFORE THE HIGH MEASUREMENT WAS RECORDED, AND NO DEVICE ISSUES WERE REPORTED AT THE PATIENT'S PRE-DISCHARGE DEVICE CHECK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331209 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR MISMATCH| E110