BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3913512 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-09003
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 11, 2014
    Report Date
    September 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 A PERFORATION OCCURRED DURING THIS RIGHT ATRIAL (RA) LEAD IMPLANTATION. RESISTANCE WAS MET WHILE INSERTING THROUGH THE CATHETER AND THE PHYSICIAN PUSHED THE LEAD THROUGH BY FORCE. THE RA LEAD WAS STUCK IN THE RA AND COULD NOT BE REMOVED HOWEVER, AFTER FEW MINUTES THE LEAD WAS MOVABLE. THE PROCEDURE WAS ABANDONED FOR THE RISK OF BLEEDING. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND LEAD WAS REMOVED THROUGH SURGICAL OPERATION. THE PATIENT WILL BE EVALUATED IN A WEEK. THE LEAD WAS NEVER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390711 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4457| 4470