BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2170334 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10128
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    January 28, 2008
    Report Date
    June 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT DURING AN ELECTIVE PROCEDURE TO REPLACE THIS PATIENT'S DEVICE, THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS AND A FRACTURE WAS REVEALED. IT WS REPORTED THAT THE PATIENT HAD EXPERIENCED AN ALL TERRAIN VEHICLE (ATV) ACCIDENT THREE YEARS PRIOR. HOWEVER, NO RV LEAD ISSUES WERE OBSERVED CLINICALLY UNTIL TODAY. THE LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT.

    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 70 YR Required Intervention 4480| 1298| 4457