BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3912586 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13225
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 8, 2014
    Report Date
    August 27, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO BACTERIAL INFECTION IN THE AORTA. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE RELATIONSHIP BETWEEN THE DEVICES AND THE INFECTION HOWEVER WAS UNSUCCESSFUL. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389891 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 4088| K173| 4470