BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3209763 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07680
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD WAS ADMITTED TO THE HOSPITAL FOR UNRELATED REASONS. INTERMITTENT AP WAS OBSERVED ON TOP OF AN R-WAVE WITH SUBSEQUENT VP ON A T-WAVE AT AN AVD OF 180 MILLISECONDS, WITH A PROGRAMMED AVD OF 210-240 MILLISECONDS. RA THRESHOLD MEASUREMENTS WERE OBSERVED TO BE 3.5 VOLTS AT 1.0 MILLISECONDS. THE RA LEAD WAS SUSPECTED TO NOT BE COMPLETELY INSERTED INTO THE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310516 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4087| A155| E110| 0158