BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 4140405 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17109
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED. NO VISUAL ANOMALIES WERE NOTED ON THE TERMINAL PIN OR TERMINAL INSULATION. THE LEAD TERMINAL END WAS PLACED IN AN IS-1 LEAD INSERTION FIXTURE AND THE FORCE MEASURED TO INSERT THE LEAD INTO THE FIXTURE WAS 1.62 LBS. THE FORCE MEASURED TO WITHDRAW THE LEAD FROM THE FIXTURE WAS 1.59 LBS. A COMPARABLE LEAD WAS INSERTED INTO THE LEAD INSERTION FIXTURE AND THE FORCE MEASURED TO INSERT THE LEAD INTO THE FIXTURE WAS 1.99 LBS. THE FORCE MEASURED TO WITHDRAW THE LEAD FROM THE FIXTURE WAS 1.97 LBS. THE LEAD WAS SEATED FULLY INTO AN IS-1 HEADER PORT OF A COMPARABLE DEVICE WITH MINIMAL RESISTANCE FELT UPON INSERTION AND WITHDRAWAL. THIS TESTING SUGGESTS THAT AN ANOMALY WITH THE LEAD ITSELF DID NOT CONTRIBUTE TO THE ALLEGATION OF LEAD INSERTION DIFFICULTY. NO OTHER TESTING WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS UNSUCCESSFULLY IMPLANTED DUE TO CONNECTION DIFFICULTY. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE REMAINS ACTIVELY IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618693 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR 4076| K062| 4457