Events

Alerta De Seguridad para Cardioversor Implantable Defibrillator TELIGEN 100 Dual Chamber - Model: E110 - Register: 10341350534 - Risk Class IV - (SERIES AFFECTED ATTACHMENT)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific do Brasil Ltda; Boston Scientific Clonmel Limited.

¿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
    1433
  • Fecha
    2014-09-23
  • 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
    Company informs that an online search tool is available at www.bostonscientific.com/ppr to determine if a particular serial / model combination is within the subset identified for public search. (LETTER TO THE PATIENT IN ANNEX).
  • Causa
    In august 2013, boston scientific reported a field action reporting that the performance of a low voltage capacitor in this subset of devices could be compromised over time, causing increased drain current, which could lead to premature battery depletion for products in relation to the subset of cognis® crt-ds and teligen® icds, manufactured before december 2009. on september 11, 2014, boston scientific identified a few more batches that may be compromised by this same situation. boston scientific has deployed and deployed a total of approximately 267,000 cognis and teligen defibrillators since may 2008. however, a subset of ~ 50,100 devices that were manufactured prior to december 2009 have shown a greater number of failures in lv capacitors (approximately 0.08% or 1 in 125). devices in this subset have not been available for implantation since november 2010. in contrast to the subset population, the lv capacitor performance decrease rate of other cognis / teligen devices (225,500) is approximately 0.0093% or 1 in 10,700. (letter to the doctor in annex).
  • Acción
    For this subset of devices, Boston Scientific recommends regular monitoring of the device as indicated on the label. You also recommend that the customer contact the Technical Services when investigating a Security Architecture alert. After the Safety Architecture or Explosion Indicator alert due to the decrease in the performance of the low voltage capacitor, the normal replacement window of three months can be reduced and the increased drain current can deplete the battery and compromise therapy / telemetry. The Technical Services sector can help estimate the availability time for device replacement if a low voltage alert or Explante indicator occurs. CRM Code 001-2014

Device

Cardioversor Implantable Defibrillator TELIGEN 100 Dual Chamber - Model: E110 - Register: 1034135...

Manufacturer

Boston Scientific do Brasil Ltda; Boston Scientific Clonmel Limited
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    ANVSANVISA