BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2051826 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03934
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED WITH THE HELIX STRETCHED AND MELTED INSULATION DUE TO ELECTROCAUTERY AT 155 MM FROM THE TERMINAL PIN. THE CONDUCTOR COILS WERE NOTED TO BE STRETCHED AT 370 TO 387 MM AND DEFORMED AT 72 TO 74 MM FROM THE TERMINAL PIN. THIS WAS MOST LIKELY DUE TO THE USE OF A GRABBING TOOL. THE FIELD ALLEGATION OF DISLODGEMENT WAS NOT CONFIRMED BY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RIGHT VENTRICULAR (RV) LEAD REVISION PROCEDURE FOR THE LOW R-WAVE MEASUREMENTS, THE RV LEAD BECAME TANGLED WITH THE RIGHT ATRIAL (RA) LEAD. TO PROVIDE ADDITIONAL SUPPORT THE PHYSICIAN USED A LOCKING STYLET THAT WAS INSERTED INTO THE RV LEAD. ADDITIONAL PRESSURE WAS APPLIED AND THE RA LEAD UNINTENTIONALLY DISLODGED FROM THE ATRIUM. THE ADDITIONAL PRESSURE ALSO CAUSED THE RV LEAD TO FRACTURE AT APPROXIMATELY THREE TO FOUR CENTIMETERS FROM THE TIP OF THE RV LEAD. THE PHYSICIAN OPTED TO LEAVE THE TIP OF THE LEAD INSIDE THE PATIENT. THE RA AND RV LEADS WERE EXPLANTED AND NEW LEADS WERE SUCCESSFULLY IMPLANTED. NO ADDITIONAL 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 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4469| 1291| 4470