BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 8712609 · Received June 19, 2019

    Report

    Report Number
    2124215-2019-11088
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    June 9, 2018
    Report Date
    June 19, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) CHANNEL OF THIS PACEMAKER SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED DATA FROM THE SYSTEM AND RECOMMENDED PERFORMING LEAD INTEGRITY TESTING. THE PHYSICIAN HAS ELECTED TO CONTINUE MONITORING THE SYSTEM. THE MAKE OF THE RV LEAD IS UNKNOWN. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504770 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 102253

    Patients

    Seq Age Sex Outcome Treatment
    1