BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE I

    MDR report key: 1798197 · Received August 12, 2010

    Report

    Report Number
    2124215-2010-12809
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 4, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. SINCE THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS FRACTURED ACCOMPANIED WITH INSULATION DAMAGE. IMPEDANCES INCREASED AND INTERMITTENT CAPTURE WAS NOTED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE I IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4451

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 4451| 4464| S606| 1688TC| 1298| 1270