Events

Safety Alert for RESONATE, VIGILANT X4, PERCIVA, and MOMENTUM CRT-D/ICD

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
    2017-10-10
  • Event Date Posted
    2017-10-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171010b.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 resonate, vigilant x4, perciva, and momentum crt-d/icd medical device manufacturer, boston scientific, has issued a medical device safety alert concerning a subset of/certain recently released resonate, vigilant x4, perciva, and momentum crt-d/icd from the united states (us) because the devices have an incorrect firmware configuration. the affected devices are identified as follows:- 1) vigilant x4 crt-d is1 df4 is4 us g247; 2) resonate el icd vr df4 us d432; 3) resonate el icd dr is1 df4 us d433; 4) momentum x4 crt-d is1 df1 is4 us g138; 5) resonate x4 crt-d is1 df4 is4 us g447. the manufacturer has received reports that when a device is interrogated by a programmer, a message presents stating“this device may contain features that are not approved and/or are investigational in some markets. do not continue without contacting boston scientific.” according to the manufacturer, the affected products were only distributed in the us. devices distributed to other countries have the correct firmware configuration. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 october 2017.

Device

RESONATE, VIGILANT X4, PERCIVA, and MOMENTUM CRT-D/ICD
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific RESONATE, VIGILANT X4, PERCIVA, and MOMENTUM CRT-D/ICD
  • 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