Events

Safety Alert for Vitatron Implantable Pacemaker C60A1 Series C - ANVISA Register 10339190181 and Vitatron Implantable Pacemaker Series T-DR T70A1 - Registration 10339190210.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Vitatron B. V..

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
    853
  • Date
    2007-02-16
  • 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
    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.
  • Reason
    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.
  • Action
    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