BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3213007 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09958
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 21, 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

    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 APPROXIMATELY FOUR DAYS POST-IMPLANT, THIS LEAD WAS CONFIRMED DISLODGED. IT WAS SUSPECTED THAT THE PRODUCT HAD RELOCATED DUE TO MULTIPLE CHEST DRAINAGE PROCEDURES, ON ACCOUNT OF A POST-PROCEDURE PNEUMOTHORAX. DURING THE REPOSITIONING ATTEMPTS, THE PHYSICIAN WAS NOT AWARE OF THE LEADS' ELECTRODE FIXATION MECHANISM AND THUS DISSATISFIED WITH THE LEADS INABILITY TO BE SUCCESSFULLY REPOSITIONED. A STABLE POSITION WAS UNATTAINABLE; NON-CAPTURE CONFIRMED AT 5V AT 0.5MS. THE LEAD WAS ULTIMATELY CUT, EXPLANTED AND DISCARDED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. A POST-EXPLANT EXAMINATION OF THE LEAD'S FIXED HELIX, SHOWED ENTWINED CARDIAC TISSUE. THE PHYSICIAN STRONGLY INDICATED A PREFERENCE FOR AN EXTENDABLE-RETRACTABLE HELIX MECHANISM. FINAL SENSING/IMPEDANCE/THRESHOLDS WERE SATISFACTORY WITH THE NEW LEAD. THE PATIENT WAS IN A STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313475 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R