BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1873923 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17871
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS IMPLANTED AND DURING THE PROCEDURE THE SUTURE SLEEVE PASSED INTO THE CEPHALIC VEIN AND WAS NOT ABLE TO BE RETRIEVED. USING A SIMILAR MODEL LEAD, THE PHYSICIAN EVALUATE THE RISK OF THE SUTURE SLEEVE PASSING OVER THE TIP OF THE LEAD AND BECOMING FREE FLOATING IN THE VENOUS SYSTEM. THE RISK WAS DETERMINED TO BE MINIMAL AS THERE WAS SIGNIFICANT RESISTANCE TO SLIDING THE SUTURE SLEEVE OVER THE RING ELECTRODE. THEREFORE THE LEAD WAS LEFT IN PLACE. TO DATE, 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 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)