BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2042450 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01218
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    December 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE LEAD WAS RETURNED SEVERED AT 109 MM FROM THE TERMINAL PIN. BOTH LEAD SEGMENTS WERE SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OF PERFORATION, HIGH THRESHOLD MEASUREMENTS AND DISLODGEMENT THAT WERE OBSERVED IN THE FIELD. ANALYSIS DID CONFIRM THAT THE LEAD WAS CUT, AS IT WAS RETURNED SEVERED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DUE TO CONCERN OVER POSSIBLE LEAD DISLODGEMENT. THE PATIENT COMMENTED THAT SHE HAD SEEN HER PHYSICIAN THE PREVIOUS WEEK AND THE PHYSICIAN HAD STATED THERE WAS CONCERN OVER LEAD MOVEMENT. THE LOCAL FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE CLINIC. THE LEAD WAS SUBSEQUENTLY EXPLANTED EIGHT MONTHS LATER DUE TO HIGH THRESHOLD MEASUREMENTS AND THE PHYSICIAN FELT THE LEAD WAS UNSTABLE. THE FIELD REPRESENTATIVE NOTED THAT DURING THE PRE-OPERATION TESTING A SURFACE ELECTROCARDIOGRAM WAS PERFORMED AND HE WAS UNABLE TO OBTAIN ANY OUT OF RANGE MEASUREMENTS FOR THE LEAD. IT WAS ALSO NOTED THAT THE LEAD WAS DIFFICULT TO REMOVE, THUS THE PHYSICIAN CUT THE LEAD IN HALF. THE PATIENT IS NOT PACEMAKER DEPENDENT AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT THE PATIENT WAS SHORT OF BREATH AND HAD A SMALL EFFUSION. IT WAS NOTED THAT DURING THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD WAS PLACED APICALLY. A PERFORATION IS SUSPECTED AS THE RV LEAD TIP IS THOUGHT TO BE SUBMUSCULAR. THE PHYSICIAN HAS OPTED TO MONITOR THE PATIENT. 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 Hospitalization| L