BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1863664 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15799
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHECK PRIOR TO A CHANGE OUT PROCEDURE, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE IMPEDANCE MEASUREMENTS. DURING THE PROCEDURE, THE RA LEAD WAS FOUND TO BE FRACTURED. THE LEAD WAS EXPLANTED AND A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THAT THE HOSPITAL KEPT THE LEAD AND SENT IT TO THEIR PATHOLOGY DEPARTMENT, SO IT IS UNKNOWN IF THE LEAD WILL BE SENT BACK FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 59 YR Hospitalization| L| R 0157| N119| H170| 4568| 4193| 0185| H177| 4537| 4470| 4480