Events

Safety Alert for Deep Brain Stimulation Lead Kits and Dystonia Kits

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
    2013-02-18
  • Event Date Posted
    2013-02-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130218.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 deep brain stimulation lead kits and dystonia kits medical device manufacturer, medtronic international limited issued a medical device safety alert concerning the following products: deep brain stimulation (dbs) lead kits: models 3387, 3387s, 3389, 3389s, 3391, 3391s dystonia kits: models 3317, 3319, 3337, 3339 medtronic has received reports of dbs leads being damaged at the connector end of the lead when the lead cap is used. tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. if this happens, the damage would most likely occur at lead contact no.3 which could affect electrode contact no.3. medtronic further explained that depending on the extent of lead damage and the need to use electrode no.3, lead replacement may be required or optimal therapy may not be provided. lead damage due to setscrew connector block twisting has been reported with 0.25% of the dbs leads distributed, however, this incidence is lower than the expected actual rate of occurrence since every event is not likely to have been reported and the actual number of uses of lead caps is unknown. according to the manufacturer, there have been no reports of permanent patient impairment, life-threatening injury, or death as a result of this issue. medtronic is working on corrective actions to reduce the occurrence of setscrew connector block twisting which may result in lead damage. physicians are reminded that every use of the lead cap provides an opportunity for lead damage to occur. the local supplier confirmed that the affected products have been distributed in hong kong. they will send a letter to relevant physicians to inform them of the risk of lead damage and the actions that should be taken to mitigate occurrence. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 february 2013.

Device

Deep Brain Stimulation Lead Kits and Dystonia Kits
  • Model / Serial
  • Product Classification
    Neurological Devices
  • Product Description
    Medical Device Safety Alert: Medtronic Deep Brain Stimulation Lead Kits and Dystonia Kits
  • 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