BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173882 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-12255
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    September 4, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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

    (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

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCES. IT WAS LATER REPORTED THAT THE IMPEDANCES ROSE TO GREATER THAN 2000 OHMS. THE PATIENT WAS BEING SEEN IN A NEW CLINIC AND REPORTED TO THE HEALTH CARE PROVIDER THAT THEY HAD BEEN PREVIOUSLY TOLD THAT THE RA LEAD WAS FRACTURED. DURING THE OFFICE VISIT, ISOMETRICS WERE PERFORMED WHICH REVEALED NO CHANGES IN IMPEDANCE AND NO NOISE. THE HEALTH CARE PROVIDER INDICATED THAT THE LEAD WAS GOING TO BE CONTINUED TO BE WATCHED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE LEAD REMAINS IN SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 4549| 4469| H220