BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2910038 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15084
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    PMA / PMN Number
    P960004
    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 ALL MEASUREMENTS DURING THE IMPLANT PROCEDURE WERE APPROPRIATE. ONE DAY POST-IMPLANT, LOSS OF CAPTURE AND A RISE IN IMPEDANCE MEASUREMENTS WERE NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16900 FINELINE II IMPLANTABLE LEAD NVN GUIDANT PUERTO RICO BV 4480

    Patients

    Seq Age Sex Outcome Treatment
    1