Events

Safety Alert for Guidant INSIGNIA and NEXUS Implantable Cardiac Pacemakers

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

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
    2005-09-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20050923.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
    Press release
  • Reason
    Safety information regarding guidant insignia and nexus implantable cardiac pacemakers september 23, 2005 the department of health has been notified by the guidant corporation of an "important medical device safety information and corrective action" concerning their insignia and nexus implantable cardiac pacemakers. the concerned pacemakers may not function properly without warning and can result in serious health complications, such as syncope which required emergency hospitalization. there have been no reported deaths associated with the malfunction of the affected pacemakers. the manufacturer has advised doctors in hospital authority and private hospitals of this important safety information. there are 115 patients implanted with the affected devices in hong kong and they will be informed by their doctors for follow up actions in a few days' time. the department of health has alerted the hospital authority, private hospitals and medical associations of this safety information.

Device

Guidant INSIGNIA and NEXUS Implantable Cardiac Pacemakers
  • Model / Serial
  • Product Description
    Press release: Safety Information
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • 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