Events

Safety Alert for SYNCHROMED II Programmable Infusion Pump - ANVISA Registration No. 10099430103.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC INC; Dabasons Ltda..

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
    1132
  • Date
    2012-04-26
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    Medtronic has confirmed that an algorithm used in the Model 8870 application card software resulted in nine (9) occurrences of an incorrect date display on the "Schedule to replace the pump by" display. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide. A patient with a pump that reaches EOS before replacement may feel the return of underlying symptoms and / or withdrawal symptoms of the drug. Patients with intrathecal baclofen may experience baclofen withdrawal, which may lead to life-threatening conditions. No adverse event was reported for eight (8) of the confirmed cases, and one patient on Intrathecal Baclofen Therapy (ITB) experienced a decrease in the therapeutic effect with increased spasticity due to the pump reaching EOS prior to replacement Recommendations: • Continue the follow-up program normal, and monitor the estimated number of months until ERI. This information can be found on the Pump Status screen, the Alarms screen, and the Print Reports Session (see Figure 2). "The" PTM® Model 8835 also indicates whether the pump has reached ERI (Pump Alarm Screen, code 8615). • Follow label recommendations for pump replacement within 90 days * from the ERI statement. To determine the ERI date, review the Pump Status screen and the Alarm screen * A minimum of 90 days at a rate of up to 1.5 mL / day, between ERI activation and EOS, according to the device label .
  • Reason
    In some circumstances after the elective replacement indicator (eri) of the pump has been displayed, the date in the "schedule to replace the pump by" display may be displayed incorrectly as a series of unknown marks (?? / ?? / ?? ??), or as a date greater than 90 days from the date of the eri, potentially leading to the pump reaching end of service (eos) before replacement.
  • Action
    The registry owner (Dabasons Ltda) informed the UTVIG that the manufacturer contacted the competent health authorities of each of the countries affected by the field action. In Brazil, the communication was made by the registry holder himself. If you have any questions, please contact your local representative or Medtronic Technical Service in Brazil. See attached.

Device

SYNCHROMED II Programmable Infusion Pump - ANVISA Registration No. 10099430103.

Manufacturer

MEDTRONIC INC; Dabasons Ltda.
  • 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
    ANVSANVISA