BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3211365 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08177
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING THE ELECTIVE PROCEDURE TO REPLACE THIS PATIENT'S DEVICE, THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING PACING INHIBITION WHICH RESULTED IN 3-4 SECONDS OF ASYSTOLE FOR THIS PATIENT. THE CLINICAL OBSERVATIONS WERE NOTED VIA TELEMETRY WHEN THE PATIENT WAS ROLLING ON HER SIDE TO GET ON AND OFF THE BED. THE PATIENT NOTED FEELING DIZZY BUT STATED SHE FEELS THAT WAY OFTEN. THE ISSUES COULD NOT BE RECREATED DURING ISOMETRICS. A LEAD FRACTURE WAS SUSPECTED AND THEREFORE, A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311597 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L 4135| 4456| 1290