BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 4132375 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14505
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THERE WAS OVERSENSING ON THIS DEVICE AND COMPETITOR RIGHT VENTRICULAR (RV) LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND CONFIRMED THE POTENTIAL FOR INTERMITTENT LOSS OF CAPTURE, LATENT CAPTURE OR EVEN COMPETITION WITH INTRINSIC CONDUCTION. IN THE EPISODES THERE IS A CHANGE IN MORPHOLOGY, LIKELY DUE TO FUSION AND THEN THE FOLLOWING BEATS EXHIBIT THE PATTERN OF SENSOR DRIVEN PACING FOLLOWED BY A SENSED EVENT IN REFRACTORY. THE SENSED EVENT AFTER THE PACED EVENT DOES NOT HAVE CONSISTENT TIMING. THE LATER TIMES LEAD TO THE SENSED EVENT FALLING OUTSIDE OF REFRACTORY AND RESETS TIMING. IT WAS UNCLEAR WITH THE AVAILABLE INFORMATION IF THERE WAS ASYSTOLE. TESTING WAS NOT ABLE TO REPRODUCE THE OBSERVATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612991 ALTRUA IMPLANTABLE PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND S501

    Patients

    Seq Age Sex Outcome Treatment
    1 S501