BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173834 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11132
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    August 23, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) EXPERIENCED TWO SYNCOPAL EPISODES DURING WHICH, INJURED HER HEAD. THE PATIENT WAS HOSPITALIZED AT WHICH TIME THE RV OUTPUT WAS INCREASED. OCCASIONAL NON-CAPTURE WAS OBSERVED AT MAXIMUM OUTPUT. THE NEXT DAY, A LEAD REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS CUT AND CAPPED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT AN INSULATION BREAK HAD BEEN SEEN ON THE LEAD. THE LOCAL FIELD REPRESENTATIVE ALSO REPORTED THAT THERE WAS KINKING OF THE LEAD NEAR THE TERMINAL PIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R 4469| 4470| S603| 1290| MISMATCH