Medtronic, Inc. (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has classified its letters to physicians related to the incompatibility of its Sutureless Connector (SC) intrathecal catheters with the IsoMed® constant-flow infusion pumps as a Class I recall. In the letters, Medtronic informed physicians that the current SC catheter labeling incorrectly states that SC catheters are compatible with the IsoMed infusion pump.

The affected products include the following models: SC Catheter and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the IsoMed Pump Model 8472, which is no longer manufactured and marketed. Medtronic stopped producing IsoMed infusion pumps in September 2008 as part of a planned product phase-out. Other types of intrathecal catheters and intravascular catheters for delivery of chemotherapy are not affected by this issue.

A physical interference between the SC catheter connector and the IsoMed pump prevents the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure. This incompatibility is design related and is not a result of implant technique. This incompatibility may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.

The clinical manifestations of an incomplete connection of an SC catheter to an IsoMed pump may include, but are not limited to, drug or cerebrospinal fluid (CSF) leakage into surrounding tissue, resulting in tissue damage, loss of or change in therapy, a return of underlying symptoms, drug withdrawal symptoms, a severe ("spinal") headache, and/or a clinically significant or fatal drug underdose. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. The IsoMed pump is not FDA approved in the United States for the administration of baclofen.

To date, Medtronic has received ten reports worldwide related to improper connection of an SC catheter to an IsoMed pump. In all ten reports, medical intervention was required to correct the condition. The ten reported events included reports of underlying symptoms, withdrawal symptoms and fluid collection in the pump pocket. In one case, it was reported that a patient death occurred two days following device revision, but it cannot be determined whether the cause of death is or is not related to the device.

The recommendations provided to physicians included directions not to use the SC catheters with an IsoMed pump. If an SC catheter is, or has been, connected to an IsoMed pump:

- Clinical judgment should be used to determine if prophylactic revision is warranted based on a patient's risk for a return of symptoms or complications due to drug withdrawal and the surgical risk of catheter revision.

- The SC catheter must not be reconnected to any other pump because the SC catheter connector may have been permanently damaged.

Medtronic is in the process of communicating with physicians and patients about this issue. Medtronic reminds patients to immediately seek medical attention if they experience a return of underlying symptoms or drug withdrawal symptoms.

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.

The FDA's classification of the voluntary recall does not alter Medtronic's patient management recommendations as provided in the August letter to physicians and risk managers. This letter, which included additional patient management information as well as catheter-pump connection recommendations, is available through Medtronic's Web site at medtronic/isomedsc.

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 fda/medwatch.

Source
Medtronic