BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 4132210 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15405
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE OVERSENSING HAD RESOLVED WITHOUT ANY FURTHER PROGRAMMING CHANGES. 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 FOLLOWING THE IMPLANT PROCEDURE FOR THIS PACEMAKER, DROPPED BEATS WERE SEEN ON TELEMETRY. ALL DIAGNOSTICS WERE GOOD AND NOISE COULD NOT BE RECREATED. A SPIKE WAS ALSO SEEN ON TELEMETRY BUT NOT SENSED BY THE DEVICE. THE SENSITIVITY WAS DECREASED FOR THE RV CHANNEL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE AIR BUBBLES IN THE DEVICE HEADER AND THAT THEY TYPICALLY DISSIPATE WITHIN 24 HOURS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613092 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4136| K063| 4135