In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
The United States Food and Drug Administration (FDA) has classified three of these notifications as Class I recalls. The fourth notification is an update to a 2011 action related to pump refill which was previously classified by the FDA as a Class I recall.
Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of symptoms or hear a device alarm, they should contact their physician immediately. No action is required of physicians beyond the recommendations provided in the notifications.
Medtronic’s intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin. These notifications do not involve Medtronic external insulin pumps for diabetes.
Specifically, the Neuromodulation business of Medtronic has initiated the following field corrective actions:
Medtronic continues to focus on improving the quality and reliability of its implantable drug infusion system. The SynchroMed Implantable Infusion System continues to demonstrate strong overall reliability, and Medtronic remains confident in its ability to deliver safe and effective therapy. Patients and caregivers should be aware of the signs and symptoms associated with intrathecal drug therapy complications and contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose. Patients with questions should contact their physicians.
Additional information is available for healthcare professionals through Medtronic’s website at http://professional.medtronic.com/iddadvisories or http://professional.medtronic.com/itbadvisories. The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Any malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at, 1-800-707-0933, Monday-Friday, 8 a.m. to 5 p.m. CDT, and the FDA’s MedWatch Program at http://www.fda.gov/MedWatch.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.