BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1873886 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17558
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    May 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC. 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

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS REMOVED ON (B)(6), 2011. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED A LEAD SAFETY SWITCH HAD OCCURRED. IN ADDITION, THERE WAS NO CAPTURE IN BIPOLAR PACING MODE. AN X-RAY WAS PERFORMED. A LEAD FRACTURE WAS CONFIRMED AT THE CEPHALIC VENOUS POINT OF LEAD ENTRY. THE LEAD WAS LEFT PROGRAMMED TO UNIPOLAR PACING MODE AND A DECISION WILL BE MADE REGARDING LEAD REPLACEMENT IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WITH THIS LEAD HAS AN INTRINISIC SINUS BRADYCARDIA 1ST DEGREE HEART BLOCK CARDIAC RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention