BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4150871 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-16244
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    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 PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PHYSICIAN REMOVED THE PREVIOUS SYSTEM. A COMPETITOR LEAD WAS PLACED ON THE RIGHT SIDE AND CONNECTED EXTERNALLY TO THE DEVICE. SUBSEQUENTLY, THE TEMPORARY PACING SYSTEM WAS REMOVED AND A NEW SYSTEM WAS IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633395 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4135| 4136| K063