Events

Safety Alert for InterStim, InterStim II, Itrel 3 and Enterra

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
    2015-01-13
  • Event Date Posted
    2015-01-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150113.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 neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation medical device manufacturer, medtronic, inc., has issued a medical device correction notice concerning interstim, interstim ii, itrel 3 and enterra devices. the manufacturer is updating the labeling related to the cycling feature in the above neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation. current labeling indicates the use of cycling improves device longevity under every programming scenario; however, enabling cycling at certain parameter settings may decrease the device battery longevity. furthermore, when cycling is enabled, longevity estimation displayed on the n’vision clinician programmer (model 8840) may not be accurate. the potential hazard would be premature battery depletion requiring an earlier than anticipated device replacement. there is no impact from this issue to therapy delivered or battery level notifications. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 january 2015.

Device

InterStim, InterStim II, Itrel 3 and Enterra
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation
  • 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