Events

REGISTER NUMBER: 10192030068. COMMERCIAL NAME: CARDIOVERSOR DEFIBRILLADOR IMPLANTAVEL BIOTRONIK. Models: TACHOS DR and TACHOS ATx. . REGISTER NUMBER: 10192030070. COMMERCIAL NAME: CARDIOVERSOR DEFIBRILLADOR IMPLANTAVEL BIOTRONIK. Models: DEIKOS (DDDRD) or TUPOS LV / A + 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
    772
  • 날짜
    2004-05-31
  • 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
    In February 2003, BIOTRONIK initiated a "Safety Alert" voluntary warning letter regarding a limited number of Deikos, Tachos and Tupos implantable cardioverter-defibrillators (ICDs), which could present an early increase in the internal impedance of their batteries. This increase in impedance could cause delays in the delivery of shocks or a reduction of energy, preventing in the worst conditions the delivery of shocks. During the interrogation of the CDIs with the software of versions A-K00.3.A or A-K00.3.A / 1 will activate a new process of automatic management of the batteries. Through this new process the battery is periodically monitored and a possible increase of the impedance of the battery is prevented. Therefore, patient safety is guaranteed during the recommended intervals between evaluations. For further information, please contact Biotronik by telephone 0800 772 12 22 or ANVISA - NATIONAL SANITARY SURVEILLANCE AGENCY Technological Surveillance Unit - UTVIG SEPN 515 - Block B - 4th. Andar - Sala 01 Asa Norte - Brasília - DF CEP: 70.770-502 Tel .: (0xx61) 448 1331/448 1485 Fax .: (0xx61) 448 1257 e-mail: tecnovigilancia@anvisa.gov.br
  • 원인
    A specific batch of these generators had a very long charging time (> 20 seconds) or very short (<7 seconds) during a 30 joule load. detailed analysis showed this behavior in generators equipped with the lis 3482 battery produced between may and october 2001. the formation of a passive layer covering the anode of the battery resulted in an increase in the internal impedance of the battery with consequent drop of the voltage during load and that potentially limits the ability of the battery to generate the full amount of energy, preventing in the worst conditions the delivery of the shock. a new batch of the mnox feedstock was introduced in the production period of the affected batch batteries. during discharge tests this feedstock presented no problem and the material passed the tests within the specified tolerances. however, the affected batteries show the formation of a metallic layer of mn in the anode due to the irregular migration of ions during the loading process. in cases where there is an increase in impedance, there is a risk of delayed delivery of the shock, preventing in the worst conditions the delivery of the same. the absence of therapy implies the non-treatment of the arrhythmia classified by the implantable cardioverter-defibrillator.
  • 조치
    To exclude or reduce this phenomenon as much as possible, it will be necessary to implement a new process of preserving the capacity of the batteries, and a constant monitoring of their internal impedance.

Device

REGISTER NUMBER: 10192030068. COMMERCIAL NAME: CARDIOVERSOR DEFIBRILLADOR IMPLANTAVEL BIOTRONIK. ...

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