BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043249 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-05151
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 26, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THE PROCEDURE TO IMPLANT THIS LEAD, THE PATIENT EXPERIENCED 10-15 SECONDS OF ASYSTOLE. A LEAD WAS PLACED IN THE PATIENTS VENTRICLE FOR PACING SUPPORT WHILE THE IMPLANT OF THIS LEAD WAS FINISHED. THERE WERE NO ADVERSE PATIENT EFFECTS FROM THE ASYSTOLE. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145846 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R 4469| 4470| K173