BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043614 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02397
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 DISPLAYED LOSS OF CAPTURE (LOC). THE PATIENT WITH THIS DEVICE SYSTEM EXHIBITED AN ESCAPE RATE AT 40BPM. SIGNIFICANT PAUSES IN PACING WERE OBSERVED, WITH RATES IN THE 20BPM RANGE. THE PATIENT EXPERIENCE MULTIPLE SYNCOPAL EPISODES AND ENDURED A CUT ABOVE THE RIGHT EYE AREA, AS WELL AS A HEMATOMA ON THE LEFT HAND. THRESHOLD MEASUREMENTS HAD NOTEDLY INCREASED FROM 0.7 V AT 0.5MS AT IMPLANT TO 3.5V AT 0.5MS. UPON REVIEW OF XRAY, THE LEAD APPEARED UNREMARKABLE, HOWEVER, THE PHYSICIAN ELECTED TO PERFORM A REVISION PROCEDURE DUE TO A CONCERN WITH RV TISSUE. THE RV LEAD WAS REPOSITIONED HIGHER ON THE RV INTERVENTRICULAR SEPTUM. NO FURTHER OBSERVATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147153 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R