BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2172940 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10207
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    September 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. SHOULD ANY FURTHER INFORMATION BECOME AVIALABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DURING THE LEAD REVISION PROCEDURE, THE PHYSICIAN WAS UNABLE TO REMOVE THE LEAD PAST THE TRICUSPID VALVUE SO HE CUT THE LEAD WHERE HE COULD REMOVE IT AND SUTURED THE REMAINING PORTION OF THE LEAD TO THE PATIENT. ONLY A SMALL PROXIMAL PORTION OF THE LEAD WAS REMOVED FROM THE PATIENT.

    Additional Manufacturer Narrative · 1

    A FEW DAYS LATER, NEW INFORMATION WAS RECEIVED INDICATING A LEAD REVISION PROCEDURE WOULD BE PERFORMED WITHIN THE NEXT WEEK. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING LOWER IMPEDANCE MEASUREMENTS AND NO SENSING, UNLESS THEY WERE PROGRAMMED UNIPOLAR CONFIGURATION DOWN TO SENSITIVITY OF .25. DURING A VENTRICULAR THRESHOLD TEST, THE DEVICE WOULD VENTRICULAR PACE, THEN WHILE LOOKING AT THE ATRIAL CHANNEL, APPROXIMATELY 160 MS LATER, A RETROGRADE WAS OBSERVED, THEN THE QRS WOULD COME THROUGH ON THE SURFACE. THE STRIPS SHOW NO PACED MORPHOLOGIES, ONLY CONDUCTED. BOTH MORPHOLOGIES WERE THE SAME WHEN TESTED AAI AND VVI MODE SO THE PHYSICIAN WASN'T CONCERNED WITH A LEADS REVERSED IN HEADER SITUATION. THE PHYSICIAN SUSPECTS THE LEAD HAD MOVED SIGNIFICANTLY BASED ON THE CLINICAL OBSERVATIONS. DUE TO THE PATIENT'S AGE AND NOT BEING PACER DEPENDENT, THE PHYSICIAN HAS ELECTED TO PROGRAM THE DEVICE DDDR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R| S 4469| S603| 4086| 4087| 1296| 4456