Events

Recall of VALITUDE CRT-P, MOMENTUM CRT-D, AUTOGEN CRT-D, VISIONIST CRT-P, DYNAGEN CRT-D

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01510-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01510-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Boston scientific has been made aware of unintended asynchronous biventricular (biv) pacing behavior when tracking elevated atrial intrinsic rhythms in certain boston scientific cardiac resynchronization therapy (crt) pacemakers (crt-ps) and defibrillators (crt-ds). repeated detection of this unintended asynchronous biv pacing behavior may result in the implanted device reverting to a permanent safety mode (safety core™) status thus requiring early replacement.
  • Action
    Doctors should review programming records of patients implanted with the CRT devices described in Appendix B of the letter. If the LV Offset parameter is programmed to a Positive value, follow the supplied instructions to determine the need for changing the pacemaker settings. Boston encourages doctors to provide the patient letter to all patients who are implanted with an affected device, and to patients who consent to having the device implanted before the software fix is available. Maintain awareness of this issue until the software fix becomes available, and display this letter in a prominent place. If a positive LV Offset is desired for a newly implanted Boston Scientific CRT device, consider the patient’s individual medical needs and either program the A-Blank after V-Pace value greater than the positive LV Offset value, or disable Tracking Preference by programming it to a value of “OFF”.

Device

VALITUDE CRT-P, MOMENTUM CRT-D, AUTOGEN CRT-D, VISIONIST CRT-P, DYNAGEN CRT-D
  • Model / Serial
    VALITUDE CRT-PModel U128ARTG 279333RESONATE CRT-DModel G447ARTG 296562MOMENTUM CRT-DModel G124, G125, G126, G128ARTG 296563, 296564, 296565, 296566AUTOGEN CRT-DModels G172, G173, G175, G177, G179ARTG 221615, 221616, 221617, 221618, 221633VISIONIST CRT-PModels U225, U226, U228ARTG 279330, 279331, 279332DYNAGEN CRT-DModels G151, G156, G158ARTG 221620, 221621, 221622
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 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
    DHTGA