BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4132167 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-16347
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THIS SYSTEM 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 CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RATE/SENSE CHANNEL. THE NOISE WAS OVERSENSED, RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND AN INAPPROPRIATE SHOCK. REVIEWED OF LEAD DIAGNOSTICS REVEALED FOUR INSTANCES OF PACING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. ADDITIONALLY, NUMEROUS NONSUSTAINED EPISODES WERE RECORDED. ATTEMPTS TO RECREATE NOISE WITH ISOMETRICS WERE UNSUCCESSFUL. DURATION WAS EXTENDED FOR BOTH THE VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) ZONES. THE PATIENT WAS REFERRED TO AN ELECTROPHYSIOLOGIST FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613027 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR E110| 5076| 4469| 0184| 1290