Events

Alerta De Seguridad para Vitatron Implantable Pacemaker C60A1 Series C - ANVISA Register 10339190181 and Vitatron Implantable Pacemaker Series T-DR T70A1 - Registration 10339190210.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Vitatron B. V..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    853
  • Fecha
    2007-02-16
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Specifically in Brazil only the models C60A1 and T70A1 were distributed. There are approximately 67,000 active Vitatron dual chamber C and T series implants worldwide. In Brazil, 1,703 units are affected. /// The Company informs that this communication is being sent to the medical societies of the Cardiology area, namely: DECA - Department of Artificial Cardiac Stimulation of the Brazilian Society of Cardiovascular Surgery and SOBRAC - Brazilian Society of Arritimias Cardíacas, as well as a letter to all the doctors and medical teams responsible for the implantation of the affected pacemakers. **** Update (11/05/2007): Medtronic Comercial Ltda announces the termination of the distribution of the update software to the company. correction of the abovementioned problem. The company also informs that it communicated the problem to the medical societies DECA and SOBRAC, as well as to all the doctors and medical teams responsible for implants of the affected pacemakers.
  • Causa
    This is a software anomaly that can affect vitatron dual-chamber c and t-series pacemakers. if this device is programmed into specific parameters, this issue may present clinically in the form of a pacemaker reset or inhibition of pacing if if the patient's intrinsic frequency falls below the programmed minimum. the problem occurs only with vitatron series c and t series dual chamber pacemakers programmed in the following ways: 1) ddd (r) or ddi (r) modes with the atrial blanking parameter in adjusted ventricular pacing below 150 milliseconds (the nominal setting for this parameter is 150 milliseconds), or 2) vdd (r) mode regardless of parameter settings. //// according to the company's information there are no reports of injuries or deaths caused by this problem. note: list of affected products, access: http: //www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2007/853.Pdf.
  • Acción
    Vitatron has developed a programmer software update that will correct the anomaly automatically during interrogation of the device, thus preventing it from occurring later. This update (Suite VSE02 version 3.0 for Model 2090 programmers) has been approved by the Dutch Certification Authority and distribution is expected to occur by the end of February 2007.

Device

Vitatron Implantable Pacemaker C60A1 Series C - ANVISA Register 10339190181 and Vitatron Implanta...

Manufacturer

Vitatron B. V.
  • Source
    ANVSANVISA