Events

Cardioversor Defibrillator - Implantable model TACHOS DR or TACHOS ATx, brand BIOTRONIK - Cardioversor Implantable Defibrillator Model DEIKOS (DDDRD) or TUPOS LV / A + and Accessories: Key, Silicone glue, Mineral oil, BIOTRONIK brand. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BIOTRONIK INDUSTRIA E COMERCIO 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
    722
  • 날짜
    2003-05-21
  • 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
    TRADING NAME: CARDIOVERSOR DEFIBRILLADOR IMPLANTAVEL BIOTRONIK - REGISTER NUMBER: 10192030068 - COMMERCIAL NAME: CARDIOVERSOR DEFIBRILADOR IMPLANTAVEL BIOTRONIK - REGISTER NUMBER: 10192030070. To date, the doctors involved have already clinically followed 38 patients from the 45 units of Tachos DR and Delkos A + with the possibility of presenting the aforementioned phenomenon, adopting the measures recommended by the BIOTRONIK headquarters. The 7 missing patients will be followed up in the next few days. BIOTRONIK will forward updated recommendations for clinical follow-up whenever new information so warrants. BIOTRONIK points out that no other CDI manufactured by Biotronik has been affected by this phenomenon. The Department of Medical Engineering-BIOTRONIK sought to clarify the recommendations of our headquarters to the medical community. However, individual circumstances may determine another medical decision about patient care and the frequency of clinical follow-ups.
  • 원인
    A limited number of implantable cardioverter-defibrillators models tachos dr, tupos lv and deikos a + have recently exhibited an inexplicable high incidence of early battery failure. biotronik berlin conducted extensive research to determine the cause of this phenomenon. a specific batch of limnox batteries used in these models was identified that presented the formation of a passive layer covering the anode of the same. this material, formed on the anode, resulted in an increase in the internal impedance of the battery with consequent decrease of the voltage during load and that potentially limits its ability to generate the necessary amount of energy, preventing in the worst conditions the delivery of the shock.
  • 조치
    Biotronik Brasil followed daily the investigations of our matrix and anticipated the measures with the medical community and patients who received the implants of the units involved in certain specific batches.

Device

Cardioversor Defibrillator - Implantable model TACHOS DR or TACHOS ATx, brand BIOTRONIK - Cardiov...

Manufacturer

BIOTRONIK INDUSTRIA E COMERCIO LTDA
  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    ANVSANVISA