BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1875012 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18598
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE COMPLETE LEAD WAS RETURNED WITH A STRETCHED HELIX. VISUAL INSPECTION FOUND THAT THE POLYURTHANE INSULATION AND A NEARBY ANODE COIL WERE MELTED. ANALYSIS CONCLUDED THAT THE LEAD DAMAGE WAS INDUCED DURING THE EXPLANT AND WAS MOST LIKELY CAUSED BY ELECTROCAUTERY.

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS. THE EVENT WILL BE UPDATED ONCE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE EXPLANTED DUE TO LOSS OF CAPTURE. IT IS UNKNOWN IF ANY DURATION OF ASYSTOLE OCCURRED. THE RA PORT ON THE DEVICE WAS PLUGGED DUE TO ATRIAL TACHYCARDIA AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    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 72 YR Hospitalization| L| R S603| 4469| 4136| 4470