SPECIAL NOTICE
65 -- Notice of Intent to Sole Source - Ten (10) MRI Compatible Stimulators, Electrical, Spinal Cord, Analgesic
- Notice Date
- 7/30/2015
- Notice Type
- Special Notice
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N0025915RCD0621
- Archive Date
- 8/28/2015
- Point of Contact
- Jayme L. Fletcher, Phone: 3016190300
- E-Mail Address
-
jayme.l.fletcher2.civ@mail.mil
(jayme.l.fletcher2.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is Medtronic USA, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432. Naval Medical Center San Diego has a requirement for ten (10) MRI compatible Stimulators, Electrical, Spinal Cord, Analgesic. The implants shall provide treatment solutions for chronic pain, by transmitting tonic electrical current pulses, via percutaneous leads, to the spinal cord, without being impacted by 1.5 Tesla magnetic resonance scans. The unit shall be implantable in the epidural space of the spine with the ability to target peripheral nerves, blocking the sensation of pain, as it varies depending on body position. The requirement includes all necessary batteries, battery chargers, trial lead kits, and general leads. Percutaneous leads shall be available in lengths up to 90 centimeters. The stimulators shall utilize up to 16 leads, with the ability to deliver a constant current and alternatively, a tonic current with widths up to 1000msec. The stimulator shall have an MRI mode, which shall be activated when the patient undergoes a magnetic resonance scan. The stimulators shall each have a rechargeable battery capable of maintaining a charge for at least 2 weeks (at medium level settings) before needing to recharge. The implanted device shall have an expected lifetime of at least 9 years. A patient shall not have to program stimulation preferences at every instance of movement or repositioning. The stimulators shall be adaptive to patient needs; the devices shall have the ability to correlate patient's ergonomic position with programmed stimulation settings. Stimulation data shall be accessible to clinicians involved in patient care, so as to optimize pain remediation. The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even if delivery is requested outside of the United States. The marketing and medical product delivery claims made for the product shall comply with United States FDA regulations, even if delivery is requested outside of the United States of America. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with OEM terms and conditions. This notice of intent is not a request for competitive proposals; however, if a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Jayme Fletcher at jayme.l.fletcher2.civ@mail.mil. In addition, challenges shall be emailed to jayme.l.fletcher2.civ@mail.mil, reference solicitation number N0025915RCD0621. Closing date for challenges is no later than 1300 Local Time, 13 August 2015. No phone calls will be accepted. Please note that a determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N0025915RCD0621/listing.html)
- Record
- SN03818047-W 20150801/150731000733-c556f0f1d4845efc1f5438b74441ff52 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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