Events

Recall of SJM Confirm External Patient Activator Model DM2100ASupplied separately or together with a SJM Confirm Implantable Cardiac Monitor (ICM) DM2100 or DM2102

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by St Jude Medical Australia 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-2013-RN-00322-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-04-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00322-1
  • 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
    St. jude medical's (sjm) data shows that two specific lots of batteries used to power the dm2100a activators may exhibit faster than normal battery depletion. dm2100a activators with batteries from affected lots may exhibit faster than normal low battery status, identified by emitting one low-pitched audible tone and flashing red lights for 9-10 seconds once every hour, or immediately when a button is pressed. additionally, in the event that an activator button is pressed and there is no indication of lights or tones, this is an indication of a depleted battery.
  • Action
    If an activator exhibits any of the above referenced issues, consumers and clinicians are asked to notify their local St. Jude Medical representative and the representative will provide a replacement activator at no cost.

Device

SJM Confirm External Patient Activator Model DM2100ASupplied separately or together with a SJM Co...
  • Model / Serial
    SJM Confirm External Patient Activator Model DM2100ASupplied separately or together with a SJM Confirm Implantable Cardiac Monitor (ICM) DM2100 or DM2102.ARTG Numbers: 160466
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • 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
    DHTGA