BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173747 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10827
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    September 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS CONFIRMED TO BE FRACTURED AT 245 MM FROM THE TERMINAL PIN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, THE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR LEAD WERE GREATER THAN 2000 OHMS. THE LEAD WAS CONFIRMED TO BE BROKEN IN HALF DUE TO CONSTANT DEVICE AND LEAD MANIPULATION BY THE PATIENT. AS A RESULT, THE LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening 1294| 4470| 4469| 4135