Problems with Medtronic Intrathecal Catheters

Medtronic has alerted healthcare professionals about the potential for misconnections between certain sutureless intrathecal catheters and the implanted infusion pumps to which they're attached. The four affected products are:

• INDURA 1P Intrathecal Catheter, model 8709SC

• Intrathecal Catheter, model 8731SC

• Sutureless Pump Connector Revision Kit, model 8578

• Intrathecal Catheter Pump Segment Revision Kit, model 8596SC

The affected catheters are used in conjunction with implanted Medtronic infusion pumps to deliver medications directly to the intrathecal space in the spine. They are used primarily to treat chronic, intractable pain and severe spasticity. The affected pumps are the SyncroMed II, SyncroMed EL and IsoMed. This action does not include Medtronic MiniMed infusion pumps.

The company says it has received reports of misalignment or incomplete connection between the sutureless pump connector and the catheter port. This can cause the catheter to disconnect from the infusion pump, or it can cause an occlusion between the catheter and the pump. In either case, the patient can experience severe underdosing. In those receiving baclofen, this can result in a withdrawal syndrome that can be fatal.

Medtronic is stressing the importance of using proper techniques when connecting the pump and catheter. This includes verifying that there is backflow of CSF through the catheter, ensuring that the sutureless connector and the pump are aligned, snapping the sutureless connector to the pump firmly, and tugging on and rotating the connection to be sure the attachment is secure.

The firm also recommends that patients and caregivers be educated to recognize the symptoms of drug underdose and withdrawal and to seek immediate medical assistance. Clinicians should keep in mind that patients who have had intrathecal therapy interrupted may be drug naïve when the therapy is resumed and so may need an adjustment in dosage.

FDA Patient Safety News: Dec. 2008

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=82#3

Category:

Education

Tags:

• Pain
• spasticity
• infusion pumps
• intrathecal catheters
• FDA
• spinal