FDA Classifies Medtronic's Notification Related To Improper Connection Of Sutureless Intrathecal Catheters As A Class I Recall

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Sep 2008 - 3:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has classified its safety alert about the proper connection of sutureless catheters used with implantable drug infusion systems as a Class I recall. The notification relates to the improper connection of its sutureless connector intrathecal catheters (referred to as SC catheters). The affected products include the following models; INDURA 1P Intrathecal Catheter, model 8709SC, Intrathecal Catheter, model 8731SC, Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.

In June 2008, Medtronic informed the FDA and clinicians worldwide that it had received reports of infusion system difficulties that were attributed to two problems. The first problem was the occlusion or improper alignment between the catheter's connector and the pump's port. The second problem was the disconnection of the catheter from the pump. Neither Medtronic's June 2008 communication, nor the FDA's classification of it as a recall, requires the explant or return of any products to Medtronic. The FDA's classification of Medtronic's safety alert is consistent with the actions previously taken by Medtronic and no new action is required of physicians beyond the recommendations listed in the June 2008 letter.

To date, Medtronic has received 83 reports of infusion system difficulties worldwide that have been attributed to either an occlusion or a disconnection of the sutureless catheter from the pump. Medtronic's investigation indicated that the events were caused by misalignment or incomplete connection of the sutureless connector on the catheter to the catheter port on the pump during the implant procedure. Analysis of the products returned indicated that when there is an occlusion (misalignment during connection), the catheter port may become embedded in the inner wall of the connector seal, rather than aligning with the connector. Improper attachment can result in catheter connector damage, leaks at the connection site, or catheter disconnection some time after implant. It is critical for the connector to be properly aligned with the port during initial attachment for the catheter to be correctly and completely connected to the pump.

The clinical signs of a possible occlusion or disconnection may include a lack of therapeutic effect, a clinically significant or fatal drug overdose or a return of underlying symptoms, and drug withdrawal symptoms. Patients receiving intrathecal baclofen therapy (e.g. Lioresal® Intrathecal) are at higher risk for adverse events as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively.

In one case, a patient died from acute baclofen withdrawal related to complications from an improperly connected catheter. A second patient death was reported after device replacement, however it was reported by the health care provider that the death was not considered to be device related. All patients experiencing an occlusion or improper connection will require a surgical procedure for correction. Medtronic's June 2008 physician letter provided specific recommendations for managing patients with implanted SC catheters including ongoing education of patients and caregivers of the signs and symptoms of drug underdose and withdrawal, as well as steps to take to identify an occlusion or disconnection, which requires a surgical procedure.

This letter, which included additional patient management information as well as catheter-pump connection recommendations, is available through Medtronic's Web site at http://www.medtronic.com/disclosure/product-advisories.html. Medtronic's intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine. These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin.

Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday - Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday, 8 a.m. to 5 p.m. CDT. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1- 800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/medwatch.

About Medtronic

Medtronic, Inc. (), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

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