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Federal Communications Commission
Washington, D.C. 20554
File No. EB-06-SE-247
In the Matter of )
NAL/Acct. No. 200732100007
Boston Scientific Corporation )
FRN # 0015229735
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")
and Parts 2 and 15 of the Commission's rules.
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,
and Sections 0.111 and 0.311 of the Commission's rules, the attached
Consent Decree IS ADOPTED.
6. IT IS FURTHER ORDERED that the Enforcement Bureau's investigation IS
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
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"), and Parts 2 and 15 of the Commission's rules.
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.
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
4. For purposes of this Consent Decree, the following definitions shall
a. "Act" means the Communications Act of 1934, as amended, 47 U.S.C. SS
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
d. "Commission" and "FCC" mean the Federal Communications Commission.
e. "Effective Date" means the date on which the Bureau releases the
f. "Investigation" means the investigation commenced by the Bureau's
June 27, 2006 Letter of Inquiry 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
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
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
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
* 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
* 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
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. S 504 and 47
C.F.R. S 1.1501 et seq., relating to the matters addressed in this
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
For: Enforcement Bureau
Federal Communications Commission
Kris Anne Monteith
Chief, Enforcement Bureau
47 U.S.C. S 302a(b).
47 C.F.R. S 2.1 et seq. and S 15.101 et seq.
47 U.S.C. S 154(i).
47 C.F.R. SS 0.111, 0.311.
47 U.S.C. S 302a(b).
47 C.F.R. S 2.1 et seq. and S 15.101 et seq.
Respironics, Inc. and Boston Scientific Corporation, Order, ET Docket No.
05-331, DA 06-2316 (OET, released November 16, 2006).
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).
Federal Communications Commission DA 06-2452