BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2052914 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03611
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST QUALITY ASSURANCE LABORATORY THE COMPLETE LEAD WAS RETURNED. VISUAL INSPECTION NOTED TWO LOOSE SUTURES AS WELL AS CUTS ON THE SUTURE SLEEVE. THE LEAD WAS ELECTRICALLY CONTINUOUS. LABORATORY ANALYSIS COULD NOT CONFIRM THE ALLEGATION RELATED TO THE DISLODGEMENT OF THIS LEAD WHILE A LOOSE SUTURE SLEEVE WAS CONFIRMED BY ANALYSIS.

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION SUGGEST THIS LEAD WILL BE RETURNED FOR ANALYSIS. UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CAME INTO THE HOSPITAL FOR A REPOSITIONING PROCEDURE, DUE THIS RIGHT VENTRICULAR (RV) LEAD DISLODGING FOR THE SECOND TIME SINCE THE IMPLANT PROCEDURE. UPON OPENING THE POCKET THE PHYSICIAN ELECTED TO REPLACE THIS RV LEAD. THE PHYSICIAN ALSO NOTED THAT DURING THE FIRST REPOSITIONING PROCEDURE OF THIS LEAD DUE TO A DISLODGEMENT THE SUTURE SLEEVE WAS LOOSE, AND IT WAS DIFFICULT TO GET THE LEAD TO STAY IN PLACE IN THE HEART. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention S603| 4480| 4457