Events

Safety Alert for Accent SR and Accent DR pacemakers

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

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
    2012-12-11
  • Event Date Posted
    2012-12-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121211b.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: st. jude medical accent sr and accent dr pacemakers the medicines and healthcare products regulatory agency(mhra), united kingdom posted a field safety notice concerning accent sr and accent dr pacemakers, manufactured by st. jude medical. the manufacturer has identified that a subset of accent sr single chamber model pm1110 and accent dr dual chamber model pm2112 pacemakers will not provide a change in sensor driven (rate responsive) pacing rates in response to patient physical activity due to an incorrect software setting. in devices programmed to a rate-responsive mode, the pacemaker will function in a basic programmed mode and will not provide a sensor driven rate increase when the patient is physically active. all other programmed parameters, features and functions operate as designed, e.G. an accent dr device programmed to dddr will appropriately track atrial activity and properly function in the ddd mode. according to the manufacturer, recall of the unimplanted products is on-going. the manufacturer advises healthcare professionals to: identify affected patient. review affected patient’s clinical indications for pacing and determine the clinical need for rate responsive, sensor driven pacing. in the event that a patient requires rate responsive sensor driven activity pacing and exhibits clinical symptoms due to the lack of increased pacing rates with exercise, contact local sales representative or technical support. continue to follow patients on their standard follow-up schedule. furthermore, according to the manufacturer, a non-invasive programmer software solution will be developed and once it is available, the sensor anomaly can be automatically corrected at follow up by a simple interrogation of the pacemaker. follow up of patients exhibiting clinical symptoms due to the lack of increased pacing rates with exercise should be prioritized. according to local supplier, the affected products were not distributed in hong kong. for details, please refer to the following mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con213146 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 december 2012.

Device

Accent SR and Accent DR pacemakers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: St. Jude Medical Accent SR and Accent DR pacemakers
  • Manufacturer
    St

Manufacturer

St
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH