BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2942530 · Received February 4, 2013

    Report

    Report Number
    2124215-2013-00997
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED OF THE FIELD REPRESENTATIVE, SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PRODUCT WAS EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46120 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4463

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 1388T| 0155| 4463| 1851| 1861| E110