BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3912469 · Received May 21, 2014

    Report

    Report Number
    3912469
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A HISTORY OF HIGH-GRADE AV BLOCK, AND HAD A PACEMAKER IMPLANTED FIVE YEARS AGO. SOON AFTER THE PACEMAKER IMPLANTATION, THE PATIENT HAD A PERFORATION OF THE RIGHT VENTRICULAR LEAD AND A NEW RIGHT VENTRICULAR LEAD WAS PLACED LAST YEAR; BYPASS SURGERY FOLLOWING THAT, WAS NOTED TO HAVE ATRIAL LEAD MALFUNCTION WITH NONCAPTURE AND POOR SENSING. THE PATIENT APPEARED TO HAVE SYMPTOMS RELATED TO PACEMAKER SYNDROME. REMOVAL OF PACEMAKER LEADS: STYLET WAS PLACED IN THE BODY OF THE LEAD AND THE LEAD WAS DISSECTED DOWN TO THE ANCHORING SLEEVE AND USING MANUAL TRACTION, THE LEAD WAS EVENTUALLY REMOVED. THE PATIENT APPEARED TO HAVE SOME ADHESIONS PROXIMAL TO THE TIP OF THE LEAD, BUT THE TIP OF THE LEAD APPEARED TO BE NORMAL WITH NO MYOCARDIAL TISSUE. THE PATIENT DID NOT HAVE ANY HEMODYNAMIC COMPROMISE DURING THIS LEAD EXTRACTION, WHICH WAS MONITORED CLOSELY WITH THE ANESTHESIOLOGIST USING TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302917 FINELINE II DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIA NVN BOSTON SCIENTIFIC CORPORATION 4470 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR