BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4140102 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17584
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE RIGHT ATRIAL (RA) LEAD AND PACEMAKER EXHIBITED IMPEDANCE MEASUREMENT ISSUES AND HIGH PACING THRESHOLD MEASUREMENTS. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE RA LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION WAS AVAILABLE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619807 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R 4479| S603| 4456| 4086| K173