BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2051571 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03161
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    December 17, 2010
    Report Date
    February 20, 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 DEVICE REMAINS IN-SERVICE. INVESTIGATION IS COMPLETED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DURING INDUCTION WITH BURST PACING THERE WAS A LOSS OF RADIO FREQUENCY TELEMETRY. THE PHYSICIAN HAD STEPPED BETWEEN THE PROGRAMMER AND THE DEVICE. AS A RESULT THE BURST PACING HAD CONTINUED, THE DEVICE DETECTED AND TREATED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ISSUE HAS BEEN MITIGATED VIA SOFTWARE MODEL 2868 VERSION 1.04.

    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