BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3930012 · Received July 11, 2014

    Report

    Report Number
    2124215-2014-13730
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    May 28, 2014
    Report Date
    February 3, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 THIS PACEMAKER AND RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE BEING OVERSENSED. SUBSEQUENTLY, A MEASURED OUT OF RANGE IMPEDANCE OF GREATER THAN 2,000 OHMS TRIGGERED THE LEAD SAFETY SWITCH (LSS) ON RA LEAD. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLE SHOOTING MEASURES. ADDITIONAL INFORMATION RECEIVED FROM A LOCAL FIELD REPRESENTATIVE INDICATING THAT THE CAUSE OF THE REPORTED OBSERVATION WAS NOT IDENTIFIED. DEVICE WAS REPROGRAMMED AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED TWO AND A HALF YEARS LATER THAT THE PACEMAKER AND RIGHT ATRIAL (RA) LEAD CONTINUED TO EXHIBIT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS AND NOISE. IT WAS NOTED THAT THE ATRIAL SENSING THRESHOLD MEASUREMENTS WERE STABLE. AT THIS TIME THE PHYSICIAN HAS OPTED TO CONTINUE TO MONITOR THE LEAD SINCE NOT PACING AT ALL IN THE ATRIUM. THE PACEMAKER WAS REPROGRAMMED AND DAILY ATRIAL MEASUREMENTS WERE PROGRAMMED OFF. THE PACEMAKER AND RA LEAD REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407180 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K174

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 5076| K174| 4087| 4088