Events

Safety Alert for Sterile packaging containing 01 Cardioversor Implantable Defibrillator Belos VR (VVIRD) and accessories: wrench, silicone glue, mineral oil.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOTRONIK INDUSTRIA E COMERCIO 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
    721
  • Date
    2003-06-02
  • 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
    PRODUCT REGISTRATION NUMBER: 10192030069 - If you have any questions, please contact the Medical Engineering Department - BIOTRONIK. Tel .: 11-5694-7772 or 11-5521-1933. Cellphone: 11-9978-3986
  • Reason
    Through letter, biotronik informed the doctors who make the evaluations of the patients involved in the cardioversors defibrillators beautiful vr. this measurement is necessary after it has been detected that there may be a defect in the high voltage capacitors of a specific production batch and that, in particular cases, can lead to non-loading of the programmed shock energy after the maximum charge time of 16 seconds. in addition, it has been observed that some capacitors have a prolonged charge time which is still within the range of 16 seconds. in these cases, these capacitors are not being reformed as often as needed. the reforms will again reduce the load times to the expected values.
  • Action
    BIOTRONIK recommends scheduling an immediate evaluation with these patients. For this purpose, the following suggestions were prepared to be followed during this clinical evaluation: 1 - On the shock list, examine the loading times for capacitor therapies and reforms. If any charging time is 16 seconds or if any power shows "???", the generator should be replaced immediately because the programmed power may not have been delivered. 2- If the generator is not recommended for replacement in item 1, use the I-K04.0.A / 1 software, which was specially designed to carry out a total of 10 capacitor changes (two with 20J, two with 25J and more 6 with 30J). The time required to complete this process will be approximately 8 minutes, with the impression of the list of shocks at the end. If any of the 10 charging times is 16 seconds or if any power value shows "???", the generator should be changed immediately because the charged power may not be the programmed power. 3- If the generator is not recommended for replacement in item 2, we recommend scheduling automatic capacitor reforming every 3 months. Patients should then follow their routine assessments. If a Belos VR generator is exchanged for the reasons explained in this notice, BIOTRONIK will offer a generator for exchange compatible with its warranty term.

Device

Sterile packaging containing 01 Cardioversor Implantable Defibrillator Belos VR (VVIRD) and acces...

Manufacturer

BIOTRONIK INDUSTRIA E COMERCIO LTDA
  • Manufacturer comment
    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