BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3904364 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09028
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 AT THE IMPLANT OF THIS DEVICE IS WAS NOTED THAT THERE WERE POTENTIAL AIR BUBBLES IN THE HEADER. THE AIR BUBBLES RESOLVED AND ARE NO LONGER PRESENT. THE DEVICE REMAINS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384368 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K174

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR K174| 1291| 4471| 4470