BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2053382 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04153
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    November 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS AND CONTINUED HIGH IMPEDANCE MEASUREMENTS. A REVISION PROCEDURE HAS BEEN SCHEDULED. IT WAS NOTED THE DEVICE HAD BEEN PROGRAMMED TO VVI MODE FOR A WHILE DUE TO THE LEAD ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS, NO SENSING, NO CAPTURE AND UNDERSENSING. A LEAD FRACTURE WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4542| 0157| 4469| H210