Important Safety Alerts

Medical device manufacturer, Medtronic, has issued a field safety notice concerning certain models of spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers.

According to the manufacturer, there will be upcoming changes to the adverse event labeling for Medtronic spinal cord stimulation therapy. Current labeling addresses the potential for neurological complications associated with the surgical implant procedure; however, they do not address the potential for epidural mass formation and subsequent spinal cord compression.

The manufacturer has identified 14 reports over the last 30 years describing delayed spinal cord compression due to an epidural mass around a Medtronic spinal cord stimulation (SCS) lead. All patients had neurological deficits and required surgical intervention to remove the mass. Histologically, the epidural masses consisted of reactive tissue (granulomatous and/or fibrous tissue). The reported time to onset of neurological symptoms after lead implant ranged from weeks to 17 years. The severity ranged from muscle weakness to progressive quadriparesis.

According to the manufacturer, the number of reports corresponds to an estimated rate of occurrence of less than 1 in 10,000 patients. The reports involved various models (8 surgical leads, 6 percutaneous leads). The data indicate that this issue is not limited to specific lead models or lead location (8 cervical, 3 thoracic, and 3 unknown). The frequency of spinal cord compression due to this issue was found to be significantly higher with the use of surgical leads and significantly higher with cervical lead location, but at least one case occurred with a percutaneous lead placed in a thoracic location.

The manufacturer advises users of the followings:

• Prophylactic removal of SCS leads is not recommended.
• If a patient with an SCS lead presents with a new neurological deficit, spinal cord compression due to reactive tissue mass formation should be considered as a potential cause.
• If an asymptomatic epidural mass is identified, periodic monitoring should be considered.

The manufacturer will arrange changes to the adverse event labeling for Medtronic spinal cord stimulation therapy.

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 13 February 2014