Events

Safety Alert for AUTOGEN DR ICDs and CRT-Ds

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific.

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
  • Date
    2014-11-18
  • Event Date Posted
    2014-11-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141118a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: boston scientific autogen dr icds and crt-ds medical device manufacturer, boston scientific, has issued a field safety notice concerning its autogen dr icds and crt-ds. the affected model numbers for autogen crt-d are g172, g173, g175, g177 and g179. the affected model numbers for autogen dr icd d046, d047, d176 and d177. according to the manufacturer, the concerned devices 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. there is no additional risk for patients in whom the rvat feature is disabled. the manufacturer is developing a software solution that will prevent this device behaviour from occurring when the rvat test feature is enabled. the software solution will be implemented via a non-invasive download from the programmer. until a software solution can be implemented, the manufacturer recommends the following: for ambulatory rvat tests, the manufacturer recommends 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, the manufacturer recommends disabling the rvat feature at the first opportunity, but within three months. for in-clinic/commanded rvat tests, the manufacturer recommends that physicians test thresholds manually, rather than utilising the automatic rvat test. according to the local supplier, boston scientific hong kong limited, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 18 november 2014.

Device

AUTOGEN DR ICDs and CRT-Ds
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific AUTOGEN DR ICDs and CRT-Ds
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    DH