BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2780943 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13125
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 25, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD AND PORTIONS OF THE SUTURE SLEEVE WILL BE RETURNED FOR ANALYSIS, BUT HAVE NOT BEEN RETURNED AS OF TODAY. THIS REPORT WILL BE REOPENED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. THE LEAD TIP AND TINES HAVE NO VISIBLE SIGNS OF DAMAGE OR DEFECT WHICH WOULD LEAD TO DISLODGEMENT. THE PHYSICIAN INDICATED WHEN TYING DOWN THE SUTURE SLEEVE THE SUTURE CUT THE LEAD IN HALF. THIS WAS CONFIRMED, THE LEAD WAS CUT/TORN IN HALF, THE CONDUCTOR COILS DEFORMED AND AN INDENT IN THE INSULATION. ALL DAMAGE WAS INDUCED FROM THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS ONE DAY POST IMPLANT. A MICRO DISLODGEMENT WAS NOTED ON FLUOROSCOPY. DURING THE REPOSITIONING PROCEDURE, THE PHYSICIAN WAS TYING DOWN THE SUTURE SLEEVE AND THE SUTURE WENT THROUGH THE SUTURE SLEEVE CUTTING IT IN HALF. THE PHYSICIAN WAS CONCERNED ABOUT THE LEAD INTEGRITY SO THE LEAD WAS EXPLANTED AND A NEW LEAD IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS 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 Hospitalization| L| R