BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3050152 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04866
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 14, 2013
    Report Date
    January 27, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED LEAD SEGMENT WAS PERFORMED. NO VISUAL AND X-RAY ANOMALIES WERE IDENTIFIED IN THE SEGMENT. RESISTANCE TESTING CONFIRMED THE ELECTRICAL CONTINUITY OF THE PORTION OF THE LEAD THAT WAS RETURNED. PRESSURE TESTING COULD NOT BE PERFORMED DUE TO AN EXTRACTION STYLET ENTANGLED WITHIN THE LEAD BODY. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVISION PROCEDURE WAS SUBSEQUENTLY PERFORMED DUE TO THE OUT OF RANGE MEASUREMENTS. THIS LEAD WAS REMOVED FROM SERVICE AND REPLACED. REMOVAL DIFFICULTY WAS EXPERIENCED DURING THE EXPLANT PROCEDURE. THE LEAD IS EXPECTED TO BE RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INCREASED PACING THRESHOLDS WERE ALSO OBSERVED. THE SITUATION CONTINUES TO BE MONITORED WITH NO PLAN OF IMMEDIATE INTERVENTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PHYSICIAN FEELS THAT SINCE THEY ARE CLOSE TO NORMAL DEVICE CHANGE OUT AND THE PATIENT DOESN'T RIGHT VENTRICULAR (RV) PACE, THEY WILL CONTINUE TO MONITOR UNTIL THE DEVICE CHANGE IS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149078 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R 4471| 4470