BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2913130 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16494
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND NO SENSING DURING PRODUCT TESTING. THE LEAD LOSS OF SENSING WAS UNABLE TO BE RESOLVED WITH THIS LEAD. THE PHYSICIAN ELECTED TO REMOVE AND REPLACE THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20442 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1