BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3120022 · Received May 10, 2013

    Report

    Report Number
    3120022
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING PLACEMENT OF AN AICD LEAD. THERE WAS DIFFICULTY GETTING THE GUIDEWIRE TO GO DOWN ON THE SVC INNOMINATE THROUGH A STANDARD 9 FRENCH SHORT SHEATH, BUT WAS SUCCESSFULLY PLACED. AS THE LEAD WAS INTRODUCED FOR PLACEMENT IN THE RIGHT ATRIUM, THE SAME DIFFICULTY WAS ENCOUNTERED. THE SHEATH WAS THEN CHANGED TO A LONG VASCULAR SHEATH. THE LEAD WAS THEN PLACED WITHOUT DIFFICULTY. THE PROCEDURALIST ATTEMPTED TO REPOSITION THE LEAD AND NOTED THAT HE FELT THAT THE GORETEX COATING HAD COME OFF OF THE LEAD. IT WAS REMOVED AND A REPLACEMENT LEAD WAS THEN INSERTED IN THE RIGHT ATRIUM WITHOUT DIFFICULTY. NO PATIENT INJURY WAS SUSTAINED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IMPLANTATION OF AICD.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205467 ENDOTAK RELIANCE LEAD, ICD NVY BOSTON SCIENTIFIC CORPORATION 0296 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR