According to a press release from the FDA, using unapproved drugs with the SynchroMed Infusion Pump may adversely affect the performance of the device and consequently could put the health of the patient in danger. According to the notification issued by the FDA, using the device with the unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. Some of the approved drugs that are allowed to be used with the pump are:

  • Floxuridine
  • Infumorp
  • Lioresal, Prialt (Ziconotide)
  • Methotrexate and Gablofen

According to the federal agency, SynchroMed EL and SynchroMed II Implantable Drug Infusion Pumps contain and administer fluids, medicines and drugs to a specific site inside the body of the patient. With this notification the FDA has recommended health care professionals, patients and doctors to use only approved drugs with the device and avoid using unapproved concentrations, compound drugs and unapproved formulations. People, individuals and healthcare professionals could find the detail information about the device Medtronic Medical Device Safety Notification issued by the company.

What is Medtronic SynchroMed® II infusion system

The SynchroMed pump brand was introduced by Medtronic in the year of 1980 and since its introduction it has pioneered intrathecal drug delivery process. The device is being widely used by doctors and healthcare professionals to offer intrathecal drug delivery from to patients. The Medtronic SynchroMed® II infusion system is the most tested and experienced implantable drug delivery system, offering unmatched reliability, demonstrating 96 percent event-free therapy.

Simply put infusion pump are medical devices that are widely used to infuse medication, drugs, fluids or nutrients into the circulatory system of patient. Though generally the device is used intravenously, subcutaneous, arterial and epidural infusions are also occasionally used. These devices could infuse and administer fluids in ways that would otherwise be expensive, impractical and unreliable. For example, they can administer as little as 0.1 mL per hour injections.

Some Important facts to know about infusion Pumps:

  • Healthcare professionals and doctors should only use pumps that are certified to have no single point of failure.
  • Batteries should always be in place so that the device can work even if the power fails or is unplugged
  • An “air-in-line” detector should be used with the device.

About Medtronic

Medtronic is one of the most renowned names in the medical device manufacturing sector that has been serving people since 1949. For more than 20 years, Medtronic has produced innovative, implantable, programmable infusion systems that precisely tailor dosing to meet individual patient needs. Medtronic was founded in 1949 in a garage in northeast Minneapolis by Earl Bakken and his brother-in-law Palmer Hermundslie as a medical equipment repair shop.