BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3052549 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03850
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS REPOSITIONED AND REMAINS IMPLANTED. 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

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD EXPERIENCED CHEST PAIN AFTER THE HELIX WAS EXTENDED. PERFORATION WAS SUSPECTED. THE LEAD WAS REPOSITIONED AND THE CHEST PAIN SUBSIDED. AN ECHOCARDIOGRAM REVEALED SOME FLUID AROUND THE HEART, BUT NO FURTHER INTERVENTION WAS REQUIRED AND THE PATIENT WAS DISCHARGED TO HOME. THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. THE SERIAL NUMBER OF THIS LEAD WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156265 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R