BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3913505 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13389
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    September 26, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED FROM FIELD REPRESENTATIVE STATING THAT THE POCKET SITE WAS OPENED AND HEMATOMA WAS SUSPECTED. THERE WAS NO INFORMATION OBTAINED TO CONFIRM THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391834 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4471| 4470| J176