BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2057573 · Received April 14, 2011

    Report

    Report Number
    2124215-2011-05622
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 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 HAS BEEN EXPLANTED AND WILL BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ONLY A PROXIMAL SEGMENT OF THE LEAD WAS RETURNED WITH A TOTAL LENGTH OF 402 MILLIMETERS. VISUAL ANALYSIS CONFIRMED DISCONTINUOUS FILARS 225 MILLIMETERS FROM THE TERMINAL PIN. THE COIL WIRES WERE FRACTURED AT THE DISTAL END OF THE RETURNED PORTION. EVIDENCE INDICATES THAT A SUTURE SLEEVE WAS LIKELY POSITIONED FROM 231-255 MILLIMETERS WHILE THE LEAD WAS IMPLANTED. IN CONCLUSION, LABORATORY ANALYSIS CONFIRMED THE FIELD ALLEGATION OF LEAD FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEAD SAFETY SWITCH FOR THIS RIGHT ATRIAL (RA) LEAD WAS ACTIVATED DUE TO HIGH IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. ADDITIONALLY, NOISE WAS NOTED ALONG WITH OVERSENSING IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. THE LEAD WAS NOT ABLE TO CAPTURE IN THE ATRIUM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE FRACTURED APPROXIMATELY 3 INCHES FROM THE TERMINAL PIN. THE LEAD WAS EXPLANTED DURING A DEVICE CHANGE OUT PROCEDURE FOR NORMAL BATTERY DEPLETION. 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 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 4034| 4472| 1298