BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2051961 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03395
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    October 12, 2010
    Report Date
    March 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME IT IS UNKNOWN IF THIS LEAD WILL BE RETURNED. UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE LEAD FAILURE WAS INTERMITTENT LOSS OF CAPTURE IN THE ATRIUM. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN ASSOCIATION WITH THE CLINICAL OBSERVATIONS. THE RA LEAD WAS EXPLANTED AND REPLACED WITH AN ACTIVE FIXATION LEAD. AT THIS TIME, THE EXPLANTED LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A UNSPECIFIED LEAD FAILURE. NO ADVERSE PATIENT EFFECTS WERE ASSOCIATED WITH THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4480| 4457| (B)(4)| (B)(4)