BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3213529 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08885
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 5, 2013
    Report Date
    July 28, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS BROKEN AND PACEMAKER DISPLAYED PACING IMPEDANCES OF GREATER THAN 2000 OHMS. THE PATIENT WAS SEEN IN CLINIC FOR FOLLOW UP. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) REPORTED THAT IMPEDANCES WERE NORMAL WITH ISOMETRICS BUT DISPLAYED IMPEDANCES OF GREATER THAN 2000 OHMS WHEN THE DEVICE WAS MANIPULATED IN THE POCKET. NOISE WAS ALSO SEEN WHICH LEAD TO INAPPROPRIATELY STORED NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. THE PATIENT WILL BE EVALUATED IN THE COMING MONTHS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT ADDITIONAL OUT OF RANGE MEASUREMENTS WERE RECORDED. A LEAD FRACTURE WAS SUSPECTED BUT UNABLE TO BE VERIFIED. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314328 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R K173| 4470