Events

Safety Alert for Name: Defibrillator for Cardiac Resynchronization Therapy MRI. Technical Name: Implantable Defibrillator for Cardiac Resynchronization Therapy. ANVISA registration number: 10341350823. Class of risk: IV. Model affected: U125; U128; U228; U225; U226 .. Serial numbers affected: See attached list

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda; Boston Scientific Limited.

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
    2454
  • Date
    2017-12-28
  • 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
    Boston Scientific is actively developing a software update designed to avoid programming a parameter-sensitive combination, the accompanying programming recommendations eliminate the risks associated with early device replacement due to this behavior of the device. CRT devices most commonly programmed for simultaneous BiV pace pacing (LV offset = zero) or sequential BiV where LV precedes RV (negative LV compensation value) are not subject to the risks described in this letter. 1. Review the patient schedule records deployed with the CRT devices included in Appendix B of the Charter. 2. If the LV Compensation parameter is set to Zero or a Negative value, the device is not at risk of this behavior. 3. If the LV Compensation parameter is set to a Positive value, determine whether the following conditions are met: A. The positive LV Compensation value exceeds the Ventricular Atrial Post-Ventricular event, where blanking "Smart" is equivalent to a value of 37.5 ms; and B. Scheduled Trace Preference for ON 4. For patients whose device has a LV Compensation value exceeding the Atrial Blanking value after ventricular event, the Trace Preference is set to ON, schedule a clinical review to reprogram the CRT device as follows, according to the individual medical needs of the patient: A. Program the CRT device so that the post-ventricular Atrial Blanking is greater than the value of the positive LV Compensation; or B. Disable the Trace Preference by programming it to a value of "OFF". 5. Devices with an Atrial Blanking post-event ventricularexcedendo the value of Positive LV Compensation are not affected and are not at risk of this behavior. 6. Patients whose device has the Scheduled Tracking Preference OFF are not affected and are not at risk from this behavior. If a positive LV Compensation is desired for a newly implanted Boston Scientific CRT device, consider the patient's individual medical needs and schedule the ventricular post-ventricular Atrial Blanking greater than the value of Positive LV Compensation, or disable the Trace Preference by scheduling it to "OFF". If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Boston scientific initiated a voluntary notification of important programming information to avoid unintended asynchronous biventricular pacing (biv) behavior by tracking elevated atrial intrinsic rhythms in certain pacemakers (crt-ps) and defibrillators (crt-ds) cardiac resynchronization therapy (crt). repeated detection of this unwanted asynchronous biv rhythm pacing behavior may result in the implanted device reverting to a permanent safety core ™ situation, thus requiring an early replacement. unintended asynchronous biv pacing pacing behavior can only occur where an infrequent combination of parameters is programmed, specifically: • left ventricular compensation (lv) programmed to a positive value that exceeds post-ventricular atrial blanking (blank-a after rhythm -v); and • trace preference = on (nominal). devices not programmed in this way are not affected. we apologize for any inconvenience this action may cause, and appreciate your understanding as we take action to ensure patient safety and customer satisfaction. we are committed to continuing to deliver products that meet the highest quality standards you expect from boston scientific.
  • Action
    Field Action Code 2017-011 triggered under the responsibility of Boston Scientific do Brasil Ltda. Will make field correction

Device

Name: Defibrillator for Cardiac Resynchronization Therapy MRI. Technical Name: Implantable Defibr...

Manufacturer

Boston Scientific do Brasil Ltda; Boston Scientific Limited
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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