Permanent motor stall could prevent the infusion of drugs to the patient, which could cause serious injury, such as drug withdrawal, the return of symptoms of underlying conditions, the need for surgery to replace the pump, or death.Medtronic has confirmed five reports of motor stall due to the presence of a foreign particle, which resulted in drug withdrawal, surgery to replace the pump, and delay of care.

An official website of the United States government: At normal body temperatures, pressurized gas that is stored below the reservoir expands, exerting constant pressure on the reservoir. Discover the benefits of targeted drug delivery. The SynchroMed™ II programmable, implantable pump delivers drug to the intrathecal space via an implanted catheter.

No deaths were reported.On October 9, 2019, Medtronic sent a letter to hospital risk managers and distributors informing them of the affected models and providing instructions on how to identify and return any affected unused product.On December 13, 2019, Medtronic issued an additional notification to healthcare providers to provide further recommendations. Prospective study of 3-year follow-up of low dose intrathecal opioids in the management of chronic nonmalignant pain. You may at any time change the settings regarding cookies.

The drug enters the pump through the reservoir fill port and passes through the reservoir valve and into the SynchroMed™ II pump reservoir. How Targeted Drug Delivery Works Recalled Product: SynchroMed II Implantable Drug Infusion Pump and SynchroMed EL Implantable Drug Infusion Pump Product Code: LKK Model Numbers: 8637 … Christopher Reis, D.O. explains conversations he has with patients about targeted drug delivery Medical Device Recalls (6:30) With an updated browser, you will have a better Medtronic website experience.

The Medtronic SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System, is used to deliver prescribed drugs into a patient’s body in a controlled manner.

The pump is used together with a catheter to deliver a specific drug to the patient’s spinal fluid.Medtronic received reports of early permanent motor stall due to the potential presence of foreign particles inside the pump motor assembly. Read our  The catheter access port (CAP) allows injection of the drug directly into the implanted catheter for drug administration and diagnostic purposes.

Christopher Reis, D.O. discusses the benefits of targeted drug delivery.

This pressure advances the drug into the SynchroMed™ II pump tubing.The peristaltic action of the SynchroMed™ II pump moves the drug from the pump reservoir, through the pump tubing, check valve, catheter port, and implanted catheter, to the infusion site.The catheter access port (CAP) allows injection of the drug directly into the implanted catheter for drug administration and diagnostic purposes. Requires interrogation to confirm pump status.Hamza M, Doleys D, Wells M, et al. The SynchroMed™ II Clinician Programmer provides a simple, guided workflow approach to programming SynchroMed™ II intrathecal pumps.The myPTM™ Personal Therapy Manager works with the SynchroMed™ II pump to help alleviate unpredictable pain.Find additional feature information along with a variety of education resources and tools.MR Yellow Triangle Under specific conditions for 1.5 T and 3.0 T MRI scans. A sixth pump, which was removed surgically due to an unrelated infection, was later found to contain a foreign particle, but there was no indication of a motor stall. The Medtronic SynchroMed II Implantable Infusion Pump recall affects units with model numbers 8637-20 and 8637-40, which were distributed between May 2004 and July 8, 2011. This site uses cookies to store information on your computer. Targeted Drug Delivery Conversations Drug injected into the CAP bypasses the SynchroMed™ II pump mechanism and goes directly through the catheter port into the implanted catheter to the infusion site.

Learn about trialing and long-term patient management. By using the site, you consent to the placement of these cookies. Five cases of motor stall have been confirmed. Some are essential to make our site work; others help us improve the user experience. LIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. (4:01) Why recommend targeted drug delivery? John Hatheway, M.D. Jay Grider, P.O., PhD, explains why he encourages the use of targeted drug delivery. SynchroMed™ II pumps can be managed using the Control WorkflowTargeted drug delivery is a safe, proven, and effective way to manage chronic pain with fewer side effects and lower doses than systemic medication. Intrathecal Drug Infusion System for Chronic Pain Management (8:24) discusses trialing & long-term management of patients with targeted drug therapy.

Learn how targeted drug delivery works to manage chronic pain. Specifically, Medtronic is not recommending prophylactic replacement of potentially affected SynchroMed II pumps, due to the low observed occurrence of motor stall from this issue, the presence of pump alarms, and the risks associated with replacement surgery.Medtronic recommends that healthcare providers discuss with patients and caregivers the signs and symptoms that could occur from a motor stall.Additionally, Medtronic advised healthcare providers to consider contacting their patients and caregivers and inform them to:Medtronic has provided healthcare providers with a list of patients who have been implanted with a potentially affected pump.Customers who have questions or need additional information or support regarding this recall should contact their Medtronic field service representative or Medtronic Technical Services at 1-800-707-0933 weekdays from 7 am to 6 pm Central Standard Time. Medtronic is recalling 11,000 SynchroMed II pumps made between May 2018 and April 2019. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is:Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66.

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