BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE

    MDR report key: 2911346 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16585
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 LEADS WERE EXPLANTED SUCCESSFULLY, HOWEVER, THE DEVICE IS CURRENTLY BEING USED AS AN EXTERNAL PACEMAKER WHILE THE INFECTION CLEARS. A NEW RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED THROUGH THE JUGULAR VEIN TO USE TEMPORARILY WITH THE PACEMAKER. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18054 SELUTE IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4285

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R K173| 4285| 1232| 4271| 1298