BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043401 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-05339
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA LEAD WAS RETURNED FOR LABORATORY ANALYSIS. ONCE ANALYSIS IS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION FOUND THAT THE LEAD¿S CONDUCTOR COILS WERE EXTREMELY STRETCHED. THE SEAL RINGS APPEAR TO BE SHAVED OFF, MOST LIKELY A RESULT OF A LASER EXTRACTION TOOL. THERE WERE CUTS IN THE INSULATION AND ELECTROCAUTERY DAMAGE NOTED ON THE LEAD BODY. AN X-RAY WAS PERFORMED AND NO VISUAL DISCONTINUITY WAS OBSERVED. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND THE MEASUREMENTS THROUGHOUT THESE TESTS WERE OUT OF SPECIFICATION. ALTHOUGH A FRACTURE WAS UNABLE TO BE VIEWED IN THE X-RAY, THERE IS A POSSIBILITY THAT THE CONDUCTOR IS FRACTURED UNDER THE ANODE RING. FURTHER TESTING WAS PERFORMED ON THE DISTAL PORTION OF THE LEAD AND IT WAS CONFIRMED THAT THE FRACTURE IS IN THE TIP SEGMENT. THE ANODE CONDUCTOR IS ALSO NO LONGER CONNECTED TO THE RING. THIS DAMAGE IS CONSISTENT WITH A LAD THAT HAD BEEN PULLED TO THE POINT OF FRACTURE. LABORATORY TESTING WAS UNABLE TO CONFIRM THE OUT OF RANGE IMPEDANCES NOTED BEFORE THE REVISION PROCEDURE. THE DAMAGE FOUND ON THIS LEAD MOST LIKELY OCCURRED DURING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD RECEIVED NUMEROUS INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR THE OVERSENSING OF NOISE. THE PACING IMPEDANCE MEASUREMENTS ON THIS RV LEAD HAVE ALSO BEEN INTERMITTENTLY ABOVE 2,000 OHMS SINCE 2012. THE DEVICE WAS PROGRAMMED TO MONITOR ONLY SO NO FURTHER SHOCKS WOULD BE DELIVERED. IN ADDITION, THE PATIENT HAS EXPERIENCED DIAPHRAGM STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD SINCE THE ASSOCIATED DEVICE WAS IMPLANTED AND THE PACING IMPEDANCE MEASUREMENTS FOR THE LV LEAD ARE ABOVE 2,000 OHMS. AS A RESULT OF THE DIAPHRAGM STIMULATION, THE DEVICE HAD BEEN REPROGRAMMED TO PACE IN THE RIGHT VENTRICLE ONLY. THERE WAS NO DEFIBRILLATION THRESHOLD (DFT) TESTING PERFORMED WHEN THE DEVICE WAS IMPLANTED BUT NORMAL SHOCK IMPEDANCE MEASUREMENTS WERE NOTED WITH ALL THE DELIVERED INAPPROPRIATE SHOCKS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE AND A TS CONSULTANT PROVIDED SOME INFORMATION AND STEPS FOR PERFORMING TROUBLESHOOTING TO ASCERTAIN THE ROOT CAUSE FOR THE ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE NOISE WAS ABLE TO BE REPRODUCED WITH ARM MOVEMENTS AND NOW THE OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ARE OBSERVED ON ALL THREE LEADS. A REVISION WAS PERFORMED AND IT WAS CONFIRMED THAT THE IS-1 PORTION OF THE RV AND LV LEAD WERE FRACTURED. THE RIGHT ATRIAL (RA) LEAD WAS ALSO EXPLANTED AS THE PATIENT IS IN CHRONIC ATRIAL FIBRILLATION. THE RV AND LV LEADS WERE SUCCESSFULLY REPLACED AND THE ATRIAL PORT OF THE DEVICE WAS PLUGGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146755 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R N119| 4538| 0181| H170| 4470