BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4132372 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14405
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE AND LEAD SYSTEM REMAINS IMPLANTED. 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 THE PATIENT IMPLANTED WITH THIS PACEMAKER AND LEAD SYSTEM EXPERIENCED A SUPERFICIAL INFECTION AT THE IMPLANT INCISION. THE PATIENT WAS HOSPITALIZED AND TREATED WITH INTRAVENOUS ANTIBIOTICS. IT WAS REPORTED THAT THE INFECTION WAS NOT BELIEVED TO BE CAUSED BY THE DEVICE OR LEADS, BUT WAS DUE TO THE IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612237 INGENIO IMPLANTABLE PULSE GENERATOR DXY GUIDANT CRM CLONMEL IRELAND K287

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 7741| K287| 7742