Events

Recall of Boston Scientific AUTOGEN DR Implantable Cardioveter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

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-2014-RN-01223-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01223-1
  • 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 autogen dr icds and crt-ds include the option of enabling a right ventricular automatic threshold (rvat) test to determine the rv pacing threshold and adjust amplitude in an ambulatory setting. if the rvat test feature is enabled and noise signals are continuously sensed within a brief rv noise window following an atrial pace, a patient may not receive effective pacing support until the rvat test ends (i.E., up to 20 cardiac cycles). although no patients have been harmed in the cases reported to date, brief periods of dizziness were reported in one case. note that there is no additional risk for patients in whom the rvat feature is disabled.
  • Action
    Boston Sci is developing a S/W solution that will prevent this device behaviour from occurring when the RVAT test feature is enabled. Following appropriate regulatory approval, this S/W solution will be implemented via a non-invasive download from the programmer. Until a S/W solution can be implemented, Boston Sci recommends the following: 1)For ambulatory RVAT tests, it is recommended that the RVAT test feature is not enabled in AUTOGEN DR ICDs and CRT-Ds, due to the potential risk of asystole occurring during the RVAT test. If the ambulatory RVAT test feature has been enabled, Boston Sci recommends disabling the RVAT feature at the first opportunity, but within 3 months. 2) For in-clinic/commanded RVAT tests, it is recommended that physicians test thresholds manually, rather than utilising the automatic RVAT test.For more information, please see http://www.tga.gov.au/alert/autogen-dr-implantable-cardioverter-defibrillator-and-autogen-cardiac-resynchronisation-therapy-defibrillator . This action has been closed-out on 18/03/2016.

Device

Boston Scientific AUTOGEN DR Implantable Cardioveter-Defibrillators (ICDs) and Cardiac Resynchron...
  • Model / Serial
    Boston Scientific AUTOGEN DR Implantable Cardioveter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) AUTOGEN CRT-D Model Numbers: G172 / G173 / G175 / G177 / G179 AUTOGEN DR ICD Model Numbers: D046 / D047 / D176 / D177 ARTG numbers: 221642, 221643, 221640, 221618, 221615, 221616, 221641, 221633, 221617
  • 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