BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4232377 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19565
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHECK THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED PACING IMPEDANCES OF GREATER THAN 200 OHMS, LOSS OF MYOCARDIAL CAPTURE AT MAXIMUM OUTPUT AND NOISE. THE LEAD WAS SUSPECTED TO HAVE FRACTURED. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS TESTED IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATION THROUGH THE DEVICE PACING SYSTEM ANALYZER (PSA). ALL TESTING YIELDED OUT OF RANGE IMPEDANCES, NON-CAPTURE AND NOISE. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715250 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4469| K173| 1290| 4136| 1283| 4456