BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3921936 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13140
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. AS THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE OF GREATER THAN 2,500 OHMS ALONG WITH NON-CAPTURE AT MAXIMUM OUTPUTS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE LEAD APPEARED TO BE FRACTURED THROUGH FLUOROSCOPY. THE LEAD WAS NOT TESTED THROUGH PACING SYSTEM ANALYZER (PSA). THE HEADER CONNECTION WAS CHECKED AND APPEARED TO BE INTACT. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401780 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R S603| 4457| 4136