BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4131782 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14035
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    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 IT WAS CHALLENGING TO IMPLANT THE RIGHT ATRIAL (RA) LEAD IN A GOOD POSITION WITH ACCEPTABLE THRESHOLD MEASUREMENTS. THE FOURTH POSITIONING YIELDED ACCEPTABLE THRESHOLD MEASUREMENTS. TWO DAYS LATER BEFORE BEING DISCHARGED, X-RAY SHOWED THE RA AND RIGHT VENTRICULAR (RV) LEADS HAD DISLOCATED. SENSING HAD DECREASED ON THE RA LEAD WITH SOME FARFIELD OVERSENSING OF THE VENTRICULAR ACTIVITY. THERE WAS ALSO LOSS OF CAPTURE AND HIGH THRESHOLD MEASUREMENTS NOTED ON THE RA LEAD. THE RV LEAD INDICATED DECREASED SENSING, HIGH THRESHOLD MEASUREMENTS AND THE FLUOROSCOPY SHOWED A LOT OF STRETCH IN THE LEAD. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED WITH APPROPRIATE MEASUREMENTS. IT TOOK 20 TURNS TO RETRACT THE RA HELIX. A NEW POSITION OF THE RA LEAD INDICATED APPROPRIATE MEASUREMENTS THROUGH THE PACING SYSTEM ANALYZER (PSA) BEFORE EXTENDING THE HELIX. HOWEVER, ATTEMPTS TO EXTEND THE HELIX WERE UNSUCCESSFUL AND THE LEAD DROPPED. THE TOOL WAS TURNED ONE TURN PER SECOND WHILE EXTENDING AND RETRACTING THE HELIX. ANOTHER ATTEMPT TO REPOSITION THE LEAD DID NOT PRODUCE A SIGNAL ON THE PSA. DUE TO THE PATIENT'S AGE AND THE RISK ASSOCIATED WITH A PUNCTURE FOR A NEW RA LEAD, IT WAS DECIDED TO EXPLANT THE RA LEAD AND PLUG THE ATRIAL PORT. THE DEVICE WAS PROGRAMMED TO VVI. IT WAS INDICATED THIS PATIENT WAS NOT PACEMAKER DEPENDENT ON RA OR RV THERAPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612691 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R 4457| 7741| J277