BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2172823 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10103
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    November 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. A FRACTURE WAS CONFIRMED 180MM FROM THE TERMINAL PIN. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    FURTHER TESTING OBSERVED THAT A MARK WAS PRESENT ON THE LEAD AT 159 MM WHICH WAS MOST LIKELY THE PROXIMAL END OF THE SUTURE SLEEVE AND SUTURE TIE-DOWN SITES AT 167 AND 176 MM INDICATE THE APPROXIMATE IMPLANTED POSITION OF THE SUTURE SLEEVE. THE CONDUCTOR COIL WAS FRACTURED AT 180 MM WHICH LIKELY CORRESPONDS TO THE DISTAL PORTION OF THE SUTURE SLEEVE POSITION. FATIGUE WAS OBSERVED ON BOTH WIRE FRACTURES ALONG WITH TITANIUM RICH INCLUSIONS AT THE ORIGINS OF EACH FRACTURE.

    Description of Event or Problem · 1

    THE RA LEAD WAS RETURNED TO ALLOW FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT ATRIAL (RA) PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,500 OHMS. THE LEAD SAFETY SWITCH WAS FOUND TO BE FLIPPED AND NO SENSING OR PACING WAS OBSERVED IN THE UNIPOLAR OR BIPOLAR MODE. THE PHYSICIAN REPROGRAMMED THE DEVICE TO VVI. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    AN INVASIVE REPOSITIONING PROCEDURE WAS PERFORMED DUE TO A SUSPECTED LEAD FRACTURE. THE RA LEAD WAS SUCCESSFULLY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 4473| 4472| 1291