BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 2210140 · Received August 12, 2011

    Report

    Report Number
    2124215-2011-13827
    Event Type
    Death
    Date Received
    August 12, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WHO HAD THIS RIGHT ATRIAL (RA) LEAD IMPLANTED PASSED AWAY FIVE DAYS AFTER THE IMPLANT PROCEDURE. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE PATIENT HAD ELEVATED POTASSIUM LEVELS AND METABOLIC ISSUES PRIOR TO THE IMPLANT PROCEDURE, AND THAT DIFFICULTIES WERE ENCOUNTERED WITH THE MAPPING AND UNSUCCESSFUL ATTEMPT TO PLACE AN INITIAL RIGHT VENTRICULAR (RV) LEAD, AND WITH MAPPING AND PLACING THIS LEAD AND A SECOND RV LEAD (FROM ANOTHER MANUFACTURER) THAT WERE EVENTUALLY IMPLANTED. DURING THE MAPPING, THE RV LEADS DEMONSTRATED HIGH AND VARYING PACE THRESHOLD MEASUREMENTS, LOW SENSING LEVELS, AND LOSS OF CAPTURE IN MOST LOCATIONS. THE ATRIAL MAPPING ALSO PRODUCED HIGH PACE THRESHOLDS AND POOR SENSING, AND THIS LEAD WAS EVENTUALLY PLACED ON THE LATERAL WALL WITH LOW P-WAVE MEASUREMENTS AND MARGINAL PACE THRESHOLDS. THE PATIENT ALSO WAS EXPERIENCING PAROXYSMAL ATRIAL TACHYCARDIA DURING THE IMPLANT PROCEDURE. IN THE DAYS FOLLOWING IMPLANT, THE PATIENT ALSO EXPERIENCED RESPIRATORY DISTRESS, AND BRADYCARDIA DUE TO LOSS OF CAPTURE WITH THE NEWLY-IMPLANTED SYSTEM. A TEMPORARY PACING SYSTEM ORIGINALLY USED WHEN THE PATIENT HAD UNDERGONE MITRAL VALVE REPAIR THE WEEK BEFORE THIS IMPLANT PROCEDURE HAD NOT YET BEEN EXPLANTED, AND WAS SUCCESSFULLY RETURNED TO SERVICE WHEN THE NEWLY-IMPLANTED SYSTEM EXHIBITED LOSS OF CAPTURE. PRIOR TO THE PATIENT'S PASSING, BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANTS AND FIELD PERSONNEL DISCUSSED THE POSSIBILITY THAT LEAD REPOSITIONING MIGHT BE REQUIRED WHEN THE PATIENT'S MEDICAL CONDITION IMPROVED AND STABILIZED. THE TEMPORARY PACING SYSTEM SUBSEQUENTLY ALSO FAILED TO PROVIDE CAPTURE AND PACING, AND THE PATIENT EVENTUALLY EXPERIENCED TERMINAL BRADYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 Death S603| 4136| 4456| 4469