BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3905381 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10675
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING THE IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD WAS FIXATED AT THE SEPTUM. WHEN A LATERAL OBLIQUE XRAY WAS VIEWED, IT WAS NOTED THE LEAD WAS NOT IN THE INTENDED SEPTUM POSITION. THE LEAD WAS ROTATED COUNTERCLOCKWISE FOR REPOSITIONING, HOWEVER THE LEAD APPEARED TENSIONED AND NO MOVEMENT WAS NOTED. THE HELIX DID NOT APPEAR TO MOVE OUT OF THE CARDIAC TISSUE. DESPITE SEVERAL ATTEMPTS TO ROTATE THE LEAD IT COULD NOT BE REMOVED. AN ECHOCARDIOGRAM WAS PERFORMED AND A PERICARDIAL EFFUSION WAS OBSERVED. THE PROCEDURE WAS ENDED. THE ATRIAL LEAD WAS EXPLANTED AND THIS LEAD WAS SURGICALLY ABANDONED. A DECISION WAS MADE TO MONITOR THIS PATIENT IN THE INTENSIVE CARE UNIT. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED AS A RESULT OF THE EFFUSION. EXHIBITED HIGH PACING THRESHOLD. OF NOTE, THIS LEAD WAS POSITIONED AT THE PULMONARY ARTERY FOR VENTRICULAR SEPTAL PACING. UPON CHECKING THE POSITION OF THE LEAD THROUGH LEFT ANTERIOR OBLIQUE (LAO) VIEW, IT WAS NOTED THAT THIS LEAD WAS NOT ORIENTED TOWARDS THE SEPTUM. SEVERAL ATTEMPTS WERE MADE TO REPOSITION THE LEAD, HOWEVER, THEY WERE NOT ABLE TO REMOVE THE LEAD. AN ECHOCARDIOGRAPHIC IMAGE WAS CHECKED AND PERICARDIAL EFFUSION WAS OBSERVED. THIS RV LEAD WAS SURGICALLY ABANDONED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383033 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 4480| 4471