Events

Safety Alert for spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-02-13
  • Event Date Posted
    2014-02-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140213.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers 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.

Device

spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient program...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH