# Before the

# Federal Communications Commission

# Washington, D.C. 20554

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| In the Matter of                 | * | File No. EB-06-SE-247         |
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| Boston Scientific Corporation    | ) | NAL/Acct. No. 200732100007    |
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|                                  | * | FRN \# 0015229735             |
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**ORDER**

**Adopted: December 5, 2006 Released: December 7, 2006**

By the Chief, Enforcement Bureau:

1.  In this Order, we adopt the attached Consent Decree entered into
    between the Enforcement Bureau and the Cardiac Rhythm Management
    business unit of Boston Scientific Corporation (hereinafter "Boston
    Scientific CRM"). The Consent Decree terminates an investigation
    initiated by the Enforcement Bureau into the use of the 90-110 kHz
    band by certain implantable cardiac devices manufactured and sold by
    Boston Scientific CRM, and the extent to which these devices have
    obtained the required equipment authorizations in compliance with
    Section 302(b) of the Communications Act of 1934, as amended
    ("Act")[^1] and Parts 2 and 15 of the Commission's rules.[^2]

2.  The Enforcement Bureau and Boston Scientific CRM have negotiated the
    terms of a Consent Decree that would resolve this matter and
    terminate the investigation. A copy of the Consent Decree is
    attached hereto and incorporated by reference.

3.  Based on the record before us, we conclude that no substantial or
    material questions of fact exist with respect to this matter as to
    whether Boston Scientific CRM possesses the basic qualifications,
    including those related to character, to hold or obtain any FCC
    license or authorization.

4.  After reviewing the terms of the Consent Decree, we find that the
    public interest would be served by adopting the Consent Decree and
    terminating the investigation.

5.  Accordingly, **IT IS ORDERED** that, pursuant to Section 4(i) of the
    Act,[^3] and Sections 0.111 and 0.311 of the Commission's rules,[^4]
    the attached Consent Decree **IS ADOPTED**.

6.  **IT IS FURTHER ORDERED** that the Enforcement Bureau's
    investigation **IS TERMINATED**.

7.  **IT IS FURTHER ORDERED** that Boston Scientific CRM shall make its
    voluntary contribution to the United States Treasury, as specified
    in the Consent Decree, by credit card through the Commission's Debt
    and Credit Management Center at (202) 418-1995, or by mailing a
    check or similar instrument, payable to the order of the Federal
    Communications Commission, to the Federal Communications Commission,
    P.O. Box 358340, Pittsburgh, PA 15251-8340. Payment by overnight
    mail may be sent to Mellon Bank/LB 358340, 500 Ross Street, Room
    1540670, Pittsburgh, PA 15251. Payment by wire transfer may be made
    to ABA Number 043000261, receiving bank Mellon Bank, and account
    number 911-6106.

8.  **IT IS FURTHER ORDERED** that a copy of this Order and Consent
    Decree shall be sent by first class mail and certified mail, return
    receipt requested, to Ronald Reimann, Jr., Boston Scientific
    Corporation, 4100 Hamline Avenue North, St. Paul, Minnesota 55112,
    and to Robert J. Ungar, Esq. and Terry G. Mahn, Esq., Fish &
    Richardson, P.C., 1425 K Street, N.W., 11^th^ Floor, Washington, DC
    20005-3500.

FEDERAL COMMUNICATIONS COMMISSION

Kris Anne Monteith

Chief, Enforcement Bureau

**CONSENT DECREE**

The Enforcement Bureau ("Bureau") of the Federal Communications
Commission (the "FCC" or "Commission") and the Cardiac Rhythm Management
business unit of Boston Scientific Corporation, (hereinafter "Boston
Scientific CRM"), by their authorized representatives, hereby enter into
this Consent Decree for the purpose of terminating the Bureau's
investigation into whether certain Boston Scientific CRM implantable
cardiac devices ("ICDs") meet the requirements of Section 302(b) of the
Communications Act of 1934, as amended (the "Act"),[^5] and Parts 2 and
15 of the Commission's rules. [^6]

**Background**

1.  Boston Scientific CRM manufactures and markets ICDs designed to
    manage heart rhythms. ICDs in three Boston Scientific CRM product
    families -- the PDM, PD2 and Contak Renewal TR/2 families -- use
    inductive coupling to provide information about heart function to
    external monitoring devices. Issues concerning radiofrequency ("RF")
    emissions in the 90-110 kHz restricted frequency band produced as a
    by-product of the inductive coupling function led Boston Scientific
    CRM to seek the advice, beginning in 2004, of the staff of the
    Office of Engineering and Technology ("OET") and the National
    Telecommunications and Information Administration ("NTIA") of the
    Department of Commerce. Boston Scientific CRM met with the
    Enforcement Bureau staff on March 23, 2006. As a result of that
    meeting, Boston Scientific CRM submitted a petition for waiver on
    June 6, 2006 to allow usage of the 90-110 kHz band for inductive
    telemetry in existing and future products until engineering changes
    could be made.[^7]

2.  On June 27, 2006, the Bureau issued a Letter of Inquiry ("LOI") to
    Boston Scientific CRM initiating an investigation into whether
    Boston Scientific CRM's inductively coupled ICDs produced RF
    emissions in the 90-110 kHz band and the extent to which Boston
    Scientific CRM had obtained Commission authorizations for its ICDs.
    Boston Scientific CRM submitted its response to the LOI on August
    10, 2006.

3.  The Bureau's investigation did not relate to the safety or efficacy
    of the Boston Scientific CRM ICDs. Rather, the investigation was
    limited to use of the 90-110 kHz restricted band and whether Boston
    Scientific CRM had the required equipment authorizations for the
    inductive (magnetic) telemetry systems in certain of Boston
    Scientific CRM's ICDs.

**Definitions**

4.  For purposes of this Consent Decree, the following definitions shall
    apply:

    a.  "Act" means the Communications Act of 1934, as amended, 47
        U.S.C. §§ 151 *et seq.*

    b.  "Adopting Order" means an Order of the Bureau adopting the terms
        and conditions of this Consent Decree.

    c.  "Bureau" means the Enforcement Bureau of the Federal
        Communications Commission.

    d.  "Commission" and "FCC" mean the Federal Communications
        Commission.

    e.  "Effective Date" means the date on which the Bureau releases the
        Adopting Order.

    f.  "Investigation" means the investigation commenced by the
        Bureau's June 27, 2006 Letter of Inquiry[^8] regarding Boston
        Scientific CRM's use of the 90-110 kHz band and whether it had
        obtained required equipment authorizations for its ICDs.

    g.  "Parties" means Boston Scientific CRM and the Bureau.

    h.  "Rules" means the Commission's Rules found in Title 47 of the
        Code of Federal Regulations.

    i.  "Boston Scientific CRM" means the Cardiac Rhythm Management
        business unit of Boston Scientific Corporation, including
        affiliates, subsidiaries and/or successors.

**Terms of Agreement**

5.  The Parties agree that the provisions of this Consent Decree shall
    be subject to final approval by the Bureau by incorporation of such
    provisions by reference in the Adopting Order.

6.  Boston Scientific CRM agrees that the Bureau has jurisdiction over
    it and the subject matter contained in this Consent Decree and the
    authority to enter into and adopt this Consent Decree.

7.  The Parties agree and acknowledge that this Consent Decree shall
    constitute a final settlement of the Investigation between Boston
    Scientific CRM and the Bureau. In express reliance on the covenants
    and representations contained herein, the Bureau agrees to terminate
    the Investigation. In consideration for the termination of this
    Investigation and in accordance with the terms of this Consent
    Decree, Boston Scientific CRM agrees to the terms, conditions and
    procedures contained herein.

8.  The Parties agree that this Consent Decree shall become binding on
    the Parties on the Effective Date. Upon release, the Adopting Order
    and this Consent Decree shall have the same force and effect as any
    other final order of the Commission and any violation of the terms
    or conditions of this Consent Decree shall constitute a violation of
    a Commission order.

9.  The Parties agree that this Consent Decree does not constitute
    either an adjudication on the merits or a factual or legal finding
    or determination regarding any compliance or noncompliance by Boston
    Scientific CRM with the requirements of the Act or the Commission's
    rules or orders. The Parties agree that this Consent Decree is for
    settlement purposes only and that by agreeing to this Consent
    Decree, Boston Scientific CRM does not admit or deny any
    noncompliance, violation, or liability associated with or arising
    from its actions or omissions involving the Act or the Commission's
    rules that are the subject of this Consent Decree.

10. Boston Scientific CRM agrees to make a voluntary contribution to the
    United States Treasury, without further protest or recourse, in the
    amount of \$25,000 within thirty (30) calendar days after the
    Effective Date of the Adopting Order. This voluntary payment does
    not constitute a fine or penalty for, or admission of, a violation
    of any law. Such contribution shall be made by credit card through
    the Commission's Debt and Credit Management Center at (202)
    418-1995, or by mailing a check or similar instrument, payable to
    the order of the Federal Communications Commission, to the Federal
    Communications Commission, P.O. Box 358340, Pittsburgh, PA
    15251-8340. Payment by overnight mail may be sent to Mellon Bank /LB
    358340, 500 Ross Street, Room 1540670, Pittsburgh, PA 15251. Payment
    by wire transfer may be made to ABA Number 043000261, receiving bank
    Mellon Bank, and account number 911-6106. The payment should
    reference NAL/Acct. No. 200732100007 and FRN \# 0015229735.

11. Boston Scientific CRM has begun and will continue to implement an
    FCC Regulatory Compliance Plan to ensure compliance with the Act,
    the Rules, and the Commission's orders. Specifically, Boston
    Scientific CRM has taken and will continue to take the following
    steps:

-   **Engineering Compliance Manager.** Boston Scientific CRM has
    appointed an Engineering Compliance Manager with oversight of FCC
    regulatory compliance for CRM devices, including verification and
    certification, input and involvement in engineering decisions, and
    access to experienced outside legal counsel with expertise in FCC
    compliance matters. Boston Scientific CRM's Engineering Compliance
    Manager has also been involved in affecting procedural and systemic
    changes to ensure FCC compliance. Boston Scientific also has a Chief
    Compliance Officer for its Cardiac Rhythm Management and Cardiac
    Surgery businesses ("CRM/CS CCO"). The CRM/CS CCO is a senior-level
    official who has the ability to effectuate change within the
    organization as necessary and to exercise independent judgment. The
    CRM/CS CCO is charged with the responsibility for developing,
    operating and monitoring the CRM compliance program, including
    providing an internal line of communication to allow confidential
    reports of potential violations. The Chief Compliance Officer
    coordinates with the Engineering Compliance Manager on engineering
    compliance matters.

-   **Staffing and Training.** Boston Scientific CRM has established an
    RF technology engineering group and trained them on FCC licensing
    and compliance, including verification and certification testing.
    Engineers in the group coordinate with the Engineering Compliance
    Manager and are involved in a variety of matters relating to radio
    frequency technology, including design evaluation, testing, and
    regulatory submissions.

-   **Product Approval and Distribution.** Boston Scientific CRM's
    product approval process and distribution process for ICDs are being
    enhanced to further ensure FCC compliance, including verification
    and certification testing of all product designs. Specifically:

    -   The Product Development Process is being formally modified to
        add a required procedure to ensure all electromagnetic energy
        transmission testing is completed and passed prior to product
        design approval. This includes verification or certification
        testing being certified by the Engineering Compliance Manager in
        writing that the product is compliant with all FCC regulations.
        This process modification will be complete by December 31, 2006.

    -   The Product Release Approval (PRA) process is being formally
        modified to include electromagnetic compliance licensing
        approvals to prevent product being sold until the Engineering
        Compliance Manager has certified in writing that the product has
        all its necessary regulatory approvals. This process
        modification will be complete by December 31, 2006.

-   **Technical Design Requirement.** Boston Scientific CRM has
    established a Technical Requirement for ICDs specifying compliance
    with the 90-110 kHz restricted band regulation for all future
    products. This Requirement will be mandated in future Boston
    Scientific CRM product definitions and specifies device testing as
    part of the product development test strategy.

-   **Interference Complaints.** Boston Scientific CRM has established a
    process for handling any interference complaints. Specifically,
    Boston Scientific CRM has ensured that any interference complaints
    are handled appropriately by Boston Scientific CRM's Technical
    Services group with support from Boston Scientific CRM's radio
    frequency engineering group.

-   **Review and Monitoring.** Boston Scientific CRM will review the FCC
    Compliance Plan annually to ensure that it is maintained in a proper
    manner and continues to address the objectives set forth therein.

12. The Bureau agrees that, in the absence of new material evidence, it
    shall not on its own motion or in response to third-party objection,
    initiate any inquiries, investigations, forfeiture proceedings,
    hearings, or other sanctions or actions against Boston Scientific
    CRM based in whole or in part on the Investigation. The Bureau also
    agrees that, in the absence of new material evidence, it will not
    initiate or recommend to the Commission any new proceeding, formal
    or informal, against Boston Scientific CRM regarding the matters
    that were the subject of the Investigation. The Bureau further
    agrees that, in the absence of new material evidence, it will not
    use the facts developed in the Investigation through the Effective
    Date to initiate on its own motion, or recommend to the Commission,
    any proceeding, formal or informal, or take any action on its own
    motion against Boston Scientific CRM with respect to Boston
    Scientific CRM's basic qualifications to hold Commission licenses or
    authorizations.

13. Boston Scientific CRM's decision to enter into this Consent Decree
    is expressly contingent upon the Bureau's issuance of an Adopting
    Order that is consistent with this Consent Decree, and which adopts
    the Consent Decree without change, addition or modification.

14. Provided the Bureau issues an Adopting Order adopting the Consent
    Decree without change, addition or modification, the Parties waive
    any and all rights they may have to seek administrative or judicial
    reconsideration, review, appeal or stay, or to otherwise challenge
    or contest the validity of this Consent Decree and the Adopting
    Order.

15. If either Party (or the United States on behalf of the Commission)
    brings a judicial action to enforce the terms of the Adopting Order,
    neither Boston Scientific CRM nor the Commission shall contest the
    validity of the Consent Decree or the Adopting Order, and Boston
    Scientific CRM and the Commission will waive any statutory right to
    a trial de novo with respect to the issuance of the Adopting Order
    and shall consent to a judgment incorporating the terms of this
    Consent Decree.

16. In the event that this Consent Decree is rendered invalid by a court
    of competent jurisdiction, it shall become null and void and may not
    be used in any manner in any legal proceeding.

17. By this Consent Decree, Boston Scientific CRM neither waives nor
    alters its right to assert and seek protection from disclosure of
    any privileged or otherwise confidential and protected documents and
    information, or to seek appropriate safeguards of confidentiality
    for any competitively sensitive or proprietary information.

18. The Parties agree that each is required to comply with each
    individual condition of this Consent Decree. Each specific condition
    is a separate condition of the Consent Decree as approved. To the
    extent that Boston Scientific CRM fails to satisfy any condition, in
    the absence of Commission alteration of the condition, it will be
    deemed noncompliant and may be subject to possible future
    enforcement action with respect to such failure to satisfy the
    condition.

19. The Parties agree that if any provision of this Consent Decree
    conflicts with any subsequent rule, order of general applicability
    or other decision of general applicability adopted by the
    Commission, that provision will be superceded by such Commission
    rule or order.

20. Boston Scientific CRM waives any rights it may have under any
    provision of the Equal Access to Justice Act, 5 U.S.C. § 504 and 47
    C.F.R. § 1.1501 *et seq*., relating to the matters addressed in this
    Consent Decree.

21. This Consent Decree cannot be modified without the advance written
    consent of both Parties.

22. The Parties agree that the requirements of this Consent Decree shall
    expire twenty-four (24) months from the Effective Date.

23. This Consent Decree may be signed in counterparts.

For: Boston Scientific Corporation

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

William F. McConnell, Jr.

Senior Vice President, Administration

Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

[]{.mark}

[]{.mark}

For: Enforcement Bureau

Federal Communications Commission

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

Kris Anne Monteith

Chief, Enforcement Bureau

Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

[^1]: 47 U.S.C. § 302a(b).

[^2]: 47 C.F.R. § 2.1 *et seq.* and § 15.101 *et seq.*

[^3]: 47 U.S.C. § 154(i).

[^4]: 47 C.F.R. §§ 0.111, 0.311.

[^5]: 47 U.S.C. § 302a(b).

[^6]: 47 C.F.R. § 2.1 *et seq.* and § 15.101 *et seq*.

[^7]: *Respironics, Inc. and Boston Scientific Corporation*, Order, ET
    Docket No. 05-331, DA 06-2316 (OET, released November 16, 2006).

[^8]: *See* Letter from Kathryn S. Berthot, Deputy Chief, Spectrum
    Enforcement Division, Enforcement Bureau, to Terry G. Mahn, Esq. and
    Robert J. Ungar, Esq., Counsel for Boston Scientific Corporation
    (June 27, 2006).