BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUNCTUA

    MDR report key: 3243673 · Received July 23, 2013

    Report

    Report Number
    2124215-2013-11786
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PACING THRESHOLD MEASUREMENTS ISSUES AND LOSS OF CAPTURE WERE NOTED ON BOTH LEFT AND RIGHT VENTRICLE DURING ABLATION PROCEDURE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED AT VVI 60BPM WITH RIGHT AND LEFT VENTRICULAR OUTPUTS AT 3.5V AT 0.4MS BEFORE THE START OF THE PROCEDURE. A MINUTE AFTER RF APPLICATION, FAILURE OF VENTRICULAR CAPTURE WERE NOTED. THE CRTD WAS RE PROGRAMMED AT A HIGHER VENTRICULAR OUTPUT OF 7.5V AT 0.4MS WHICH RESOLVED THE ISSUE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED THAT IT IS A POTENTIAL EXPECTED BEHAVIOR DUE TO INTERACTION BETWEEN ELECTRICAL CURRENT CONDUCTED BETWEEN ELECTRODES. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343805 PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P053

    Patients

    Seq Age Sex Outcome Treatment
    1