BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3210999 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07968
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 16, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND SUSPECTS THE LEAD INTEGRITY IS COMPROMISED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUBSEQUENTLY REMOVED FROM SERVICE FOLLOWING THE DEATH OF THIS PATIENT FOR OTHER CARDIAC REASONS. UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION WAS PERFORMED OF THE RETURNED PROXIMAL SEGMENT. VISUAL INSPECTION NOTED THE LEAD HAD BEEN SEVERED 117MM FROM THE TERMINAL PIN. RESISTANCE TESTING CONFIRMED THE ELECTRICAL CONTINUITY OF THE RETURNED SEGMENT. 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 ATRIAL LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS WITH SOME NOISE AND DECREASED P-WAVE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310181 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 4549| E110| H177| 4047| 4470