Events

Safety Alert for Intrathecal catheter Ascenda

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Neuromodulatiòn.

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
  • Event ID
    I1408-318
  • Event Number
    2011DM-0008132
  • Date
    2014-08-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=198
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has detected that the component of the retaining ring does not meet the manufacturing specifications, leading to potentially adverse events occurring on the patient.

Device

Intrathecal catheter Ascenda
  • Model / Serial
    878,187,808,784
  • Product Description
    It is indicated for use when the patient's therapy requires cornica medication infusion. The system is approved for use with: sterile solution of demorphine hydrochloride / morphine sulfate free of preservatives in the treatment of intractable chronic pain. Intrathecal injection debaclofen in the management of severe spasticity. Sterile solution of ziconotide free of condoms for severe chronic pain management. chronic intravascular infusion defloxuridine and methotrexate for the treatment of primary or metastatic cancer (not for use with the intrathecal catheter ascends)
  • Manufacturer
    Medtronic Neuromodulatiòn

Manufacturer

Medtronic Neuromodulatiòn
  • 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
    NIDFSINVIMA