BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3210087 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06888
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. THE LEAD WAS FRACTURED DISTAL TO THE SUTURE SLEEVE 165MM FROM THE TERMINAL PIN AND THE LEAD WAS RETURNED IN TWO SEGMENTS. THERE WERE STRETCHED CONDUCTOR COILS 556 ¿ 587 MM FROM THE TERMINAL PIN. THE CONDUCTOR COILS WERE DEFORMED 175, 377, 395 AND 411 MM FROM THE TERMINAL PIN. THIS DAMAGE WAS MOST LIKELY DUE TO A GRABBING TOOL. THERE WAS LEAD ON CAN ABRASION 68 MM FROM THE TERMINAL PIN. DUE TO THE LOCATION OF THE FRACTURE, THE DAMAGE WAS CONSISTENT WITH A FATIGUE FRACTURE NEAR THE SUTURE SLEEVE TIE DOWN AREA.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE IN ATRIAL TACHY RESPONSE (ATR) EVENTS. POCKET MANIPULATIONS ALSO NOTED NOISE. THE LEAD WAS EXPLANTED AND REPLACED AS INSULATION DAMAGE OR LEAD FRACTURE WERE SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309461 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R