Events

Safety Alert for Trade name: Double Chamber 2 Step Marker (Ingenio 2). Technical Name: Dual Chamber Implantable Cardiac pacemaker, with Frequency Response. ANVISA registration number: 10341350822. Risk class: IV. Model affected: L201; L211; L231; L331; L311; L221; S702; S722. Affected serial numbers: See attached list at Anvisa portal - link: http://portal.anvisa.gov.br/informacoes-tecnicas13?p_p_id=101_INSTANCE_WvKKx2fhdjM2&p;_p_col_id=column-2&p;_p_col_pos=1&p;_p_col_count=2&_101_INSTANCE_WvKKx2fhdjM2_groupId=33868&_101_INSTANCE_WvKKx2fhdjM2_urlTitle = alert-2453-technical surveillance-Boston-pacemaker--tube-two-2-Ingenio-2-failure-in-signal-of-sensor-to-ventilation-minimal & _101_INSTANCE_WvKKx2fhdjM2_struts_action =% 2Fasset_publisher% 2Fview_content & _101_INSTANCE_WvKKx2fhdjM2_assetEntryId = 3908969 & _101_INSTANCE_WvKKx2fhdjM2_type = content

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
    2453
  • 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 upgrade designed to automatically detect and resolve this signal over-detection behavior of the MV sensor. Until software is available to automatically resolve MV sensor signal over-detection, Boston Scientific recommends managing the risk for patients implanted with affected pacemaker systems as follows: • For pacemaker dependent patients, change the MV sensor to "OFF". Note that when programmed to passive, the MV sensor signal is enabled and may be over-detected. See Appendix B for details on changing the MV sensor to "OFF". • For all other patients, evaluate the risks of over-detection of the MV sensor signal against the benefits of the pace indicated on the MV sensor. If the risk exceeds the benefit, change the MV sensor to "OFF" (see Appendix B). • If out-of-range, transient, or abrupt changes in RA / RV rhythm impedance measurements are observed, contact Boston Scientific Technical Services to explore all noninvasive programming options before surgery. In most cases, system management can be done non-invasively through schedule changes. • According to the manual of the pacemaker, if MV sensor signal artifacts are observed in EGMs and the electrodes are working properly, consider programming the sensor to "OFF" to avoid over detection. • For patients with the MV sensor enabled, periodically reassess the dependence of the pacemaker. 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 voluntary notification from reports of intermittent over-detection of minimal ventilation (mv) sensor signal with certain pacemakers and cardiac resynchronization pacing systems from boston scientific. it has been shown that a high potential of mv sensor signal over-detection in certain pacemaker systems connected to competitors pacing electrodes. although all electrodes evaluated in simulated test environments comply with the appropriate connector standards, boston scientific has observed subtle differences between electrode manufacturers in the electrode end ring surface finish and amount of axial and radial terminal ring movement within the electrode pacemaker connector block. these factors can result in intermittent increases in impedance leading to over-detection of the mv sensor signal or changes in impedance test measurements daily. 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

Trade name: Double Chamber 2 Step Marker (Ingenio 2). Technical Name: Dual Chamber Implantable Ca...

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