Events

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). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Medtronic Inc; Dabasons Imp. Exp. e Comércio Ltda 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    913
  • 날짜
    2008-05-20
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    Possibility of inflammatory mass formation at the tip of the intrathecal catheter used in isomed and synchromed ii implantable infusion pumps.
  • 조치
    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
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “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