BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1771397 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12471
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF NEW INFORMATION IS FORWARDED, THE EVENT WILL BE REOPENED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE CLINICAL FOLLOW-UP, LOSS OF CAPTURE AND UNDERSENSING WERE OBSERVED WITH THIS RIGHT VENTRICULAR LEAD. THE LEAD WAS CONFIRMED DISLODGED AND THE DEVICE REPROGRAMMED TO AAI. 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 77 YR Required Intervention 4480| S602| 4457