Events

Recall of Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in the management of hydrocephalus

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00155-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00155-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The identified products may have a rare condition related to the strata valve that can lead to an inaccurate pressure level (pl) reading on the strata indicator tool or stratavarius system. the condition occurs when the magnet inside the valve becomes reverse polarised, which may occur only if a patient has been exposed to 3t mri magnetic field or greater, and biological debris is present to an extent that the valve magnet adjustment mechanism is impacted. medtronic's investigation identifies that a reverse-polarity magnet has a relatively small chance of occurrence (rate: 0.007% over a two year period). over the two year period, a total of five complaints received included three adverse events (three revision surgeries). however, only one revision surgery was confirmed to occur due to the reported product problem. there have been no reports of other instances of disease, illness, or injury.
  • Action
    Clinicians are advised that the expected adverse health consequences are the same as those experienced during the course of hydrocephalus management (eg. headaches, lethargy, nausea, vomiting), or those related to a revision surgery).The IFU for the products is being updated to include the following verbiage to reinforce the warnings/precautions: “Biological debris inside the valve may impact adjustability, and may lead to adjustment mechanism damage if exposed to 3.0 tesla MRI. If difficulty is experienced adjusting or reading the valve setting, radiographic setting confirmation should be considered. The reading from the Strata II Indicator tool or StrataVarius system may be reversed (180 degrees opposite) from the radiographic image. In this situation, radiographic imaging should be used to determine the setting of the valve.” For further information, please refer to: https://www.tga.gov.au/alert/medtronic-strata-ii-strata-nsc-valves .

Device

Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in th...
  • Model / Serial
    Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in the management of hydrocephalusMultiple Catalogue NumbersAll Lot NumbersARTG Numbers: 111909, 129681, 134740, 145335, 145337, 165018, 169054, 169061
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA