BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1771465 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12525
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS REPROGRAMMED AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED INAPPROPRIATE THE MORNING AFTER THE IMPLANT PROCEDURE. THE LEAD APPEARED TO BE UNDERSENSING AND THE R WAVE HAD DECREASED. LEAD DISLODGEMENT WAS SUSPECTED. THE DEVICE WAS REPROGRAMMED TO AUTO-SENSITIVITY. THE PATIENT'S PHYSICIAN WAS TO EVALUATE THE PATIENT TO DETERMINE IF REPOSITIONING WAS NECESSARY. 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 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening