BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1862161 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15863
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT CAME IN FOR HER FIRST FOLLOW-UP VISIT FIVE AND A HALF MONTHS POST IMPLANT. DURING THE DEVICE INTERROGATION, IT WAS NOTED THAT THE P-WAVE AMPLITUDE WAS LOW AND THE RIGHT ATRIAL (RA) LEAD THRESHOLD MEASUREMENT WAS HIGH. ON THE X-RAY, THE RA LEAD WAS NOTED TO HAVE A LOT OF SLACK AND THE LEAD APPEARED TO HAVE DISLODGED. A LEAD REVISION PROCEDURE WAS SCHEDULED FOR THE FOLLOWING DAY.

    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 39 YR Hospitalization| L| R 4470| S603| 4469