BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE I

    MDR report key: 1952179 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23631
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    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

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE I IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4450

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention (B)(4)| 4450| 1283