BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3052788 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04944
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 REVISION PROCEDURE, THE TERMINAL PIN OF THIS RIGHT ATRIAL (RA) LEAD DISCONNECTED FROM THE LEAD BODY. THIS OCCURRED WHEN TISSUE WAS PULLED OFF OF THE LEAD. THE LEAD COIL BECAME VISABLE. THE LEAD WAS SURGICALLY ABANDONED AND ANOTHER RA LEAD WITH THE SAME MODEL NUMBER WAS PLACED, INSTEAD. A CHECK WAS PERFORMED THE NEXT MORNING AND EVERYTHING WAS FINE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155652 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 4456| 1298| S403| 4469