BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043224 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02146
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    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 THIS RIGHT VENTRICULAR (RV) LEAD HAD BEEN PLACED IN THE LEFT VENTRICULAR (LV) LEAD, THROUGH THE SUBCLAVIAN ARTERY UNINTENTIONALLY. IT WAS THOUGHT THAT A CLOT HAD POTENTIALLY FORMED FROM THE LEAD. THIS PACER DEPENDENT PATIENT WITH ATRIAL FIBRILLATION (AF) AND DEVICE SYSTEM ENDURED A STROKE. THE PATIENT'S PHYSICIAN THOUGHT THE STROKE COULD BE A RESULT OF THE CLOT RESULTING FROM THE LEAD PLACEMENT OR ATRIAL FIBRILLATION (AF). THE PATIENT WAS CURRENTLY NON-VERBAL AND BEING FED THROUGH A FEEDING TUBE AND RESTRICTED TO THE BED. NO REVISION PROCEDURE WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147081 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L 1194| 4457| 4470| 4480