Events

Safety Alert for ISOMED Implantable Infusion Pumps (Mod. 8472-20, 8472-35, 8472-60) and SYNCHROMED II (Mod. 8637-20 and 8637-40). Anvisa registration number: 10099430095 (ISOMED) and 10099430103 (SYNCHROMED II).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Inc; Dabasons Imp. Exp. e Comércio 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
    913
  • Date
    2008-05-20
  • 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 Inc. recently conducted a survey of the occurrence of chronic inflammation or granuloma in the distal portion of intrathecal catheters used in implantable infusion pumps (IsoMed, SynchroMed II and SynchroMed EL), particularly in cases of use of these same pumps in opioid infusion therapies, baclofen, drug-drug compounds and other pharmacological preparations. The exact cause of inflammatory mass formation is still unknown, but the higher rate of occurrence of this problem is associated with the use of opioids, particularly when using high doses, or high concentration doses, of morphine sulfate and / or other opioids. In December 2007, the company estimated the incidence rate of inflammatory mass (from reported cases) in patients implanted and submitted to infusion of drugs for pain treatment by 0.49%, higher than the incidence rate of 0, 1% reported in 2001. Medtronic Inc.'s expectation is that the rate of reported occurrences of this problem will increase as cases of this type have occurred between 6 months and> 10 years after implantation of the infusion device in patients. The symptoms reported in patients are as follows: decreased therapeutic response / inadequate attenuation of pain, pain, neurological dysfunction, paralysis / paraplegia, muscle weakness / weakness, numbness, incontinence, motor difficulties, urinary retention, tingling sensation, and headache . The risk of this problem occurring seems to be cumulative over time and increases as higher concentrations of opioids are used in the treatment.
  • Reason
    Possibility of inflammatory mass formation at the tip of the intrathecal catheter used in isomed and synchromed ii implantable infusion pumps.
  • Action
    The company that manufactures the product (Medtronic Inc. - USA) recommends that intrathecal opioids be administered in a way to provide an adequate analgesic action using the lowest doses possible. Physicians who accompany patients implanted with these infusion pumps should implant a routine of monitoring specific to the needs of each patient, aiming to identify the formation of inflammatory mass from clinical signs and symptoms presented. Special attention should be given to patients whose implant is used for infusion of drug-compound drugs, or preparations that include baclofen and opioids. The company currently in possession of the product registration in Brazil (DABASONS LTDA) informed the Anvisa's Technovigilance Unit that it has already initiated contact with its clients involved in this action, through letters of communication. According to the company, 484 units of these devices were marketed in Brazil to date, and there are also 28 non-marketed units retained in stock. The company said it had not marketed the Synchromed EL (also at risk) implantable infusion pump in Brazil. Anvisa's Technovigilance unit is following up on this case.

Device

ISOMED Implantable Infusion Pumps (Mod. 8472-20, 8472-35, 8472-60) and SYNCHROMED II (Mod. 8637-2...

Manufacturer

Medtronic Inc; Dabasons Imp. Exp. e Comércio 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