BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1875130 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18275
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 30, 2010
    Report Date
    November 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, INFORMATION WAS RECEIVED INDICATING THAT THIS DEVICE SYSTEM WAS REMOVED FROM SERVICE AS A RESULT OF INFECTION. TO DATE, ASSOCIATED MEDICAL DEVICES HAVE NOT BEEN RETURNED TO THE BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY. THIS INVESTIGATION WILL NOW BE RE-CLOSED. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE SYSTEM REMAINED ACTIVELY IN SERVICE, HOWEVER MEDICAL (PHARMACEUTICAL) INTERVENTION OCCURRED DUE TO POCKET INFECTION THAT WAS PRESENT THREE DAYS POST-IMPLANT. THE PATIENT INDICATED THAT A SMALL AMOUNT OF INFECTED AREA YET REMAINS AT THE DEVICE SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention H227| 4592| 4470| 4555| 0185