BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2051964 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03933
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED WITH A TOTAL LENGTH OF 590 MM AND THE TIP OF THE LEAD MISSING. DRIED BODY FLUID WAS SEEN THROUGH OUT THE ENTIRE LEAD LUMEN AND THE EXTRACTION STYLET WAS RETURNED STUCK INSIDE THE LEAD. VISUAL INSPECTION REVEALED STRETCHED CONDUCTOR COILS AT 458 TO 590 MM FROM THE TERMINAL PIN AND MELTED INSULATION FROM ELECTROCAUTERY AT 99 TO 105 AND 133 MM FROM THE TERMINAL PIN. THE ALLEGATION THAT PRESSURE CAUSED THE RV LEAD TO FRACTURE WAS CONFIRMED AS THE LEAD WAS STRETCHED TO A DUCTILE FRACTURE. HOWEVER, THE ALLEGATION OF LOW R-WAVE MEASUREMENTS WAS NOT ABLE TO BE CONFIRMED BY LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

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

    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 4470

    Patients

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