*Pages 1--7 from Microsoft Word - 61442.doc* Federal Communications Commission DA 06- 2452 1 Before the Federal Communications Commission Washington, D. C. 20554 In the Matter of Boston Scientific Corporation ) ) ) ) File No. EB- 06- SE- 247 NAL/ Acct. No. 200732100007 FRN # 0015229735 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 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. 1 Federal Communications Commission DA 06- 2452 2 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 2 Federal Communications Commission DA 06- 2452 1 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. 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). 3 Federal Communications Commission DA 06- 2452 2 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 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). 4 Federal Communications Commission DA 06- 2452 5 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: ___________________________ For: Enforcement Bureau Federal Communications Commission ____________________________ Kris Anne Monteith Chief, Enforcement Bureau Date: __________________________ 7