BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3910501 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-10712
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. ADDITIONAL INFORMATION RECEIVED THAT THIS PATIENT IS KNOWN TO BE PACER DEPENDENT; THUS, THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND WAS USED AS A TEMPORARY RIGHT VENTRICULAR (RV) PACER. THIS TEMPORARY PACING WILL BE IN PLACE UNTIL INFECTION IS CLEARED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387947 INGENIO IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND V173

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| R 4047| V173| 1688TC| 1488TC| 5386