BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE I

    MDR report key: 1862192 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15609
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE WE WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A RECENT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD WAS NOTED AS HAVING BEEN SURGICALLY ABANDONED IN AN EARLIER PROCEDURE. THE REASON THE LEAD WAS REMOVED FROM SERVICE WAS NOT REPORTED TO OUR COMPANY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE I IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 4451

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R 4451| 1283| 4137| 4476| SEDR01| 1388TC| 1273