Events

Recall of Nanostim Leadless Cardiac Pacemaker (LCP)

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-2016-RN-01460-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-11-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01460-1
  • 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 (sjm) has identified that patients with nanostim leadless cardiac pacemakers may experience loss of telemetry and pacing due to battery malfunction. investigation by sjm found decreased battery capacity due to reduced electrolyte, resulting in high internal battery resistance. this disrupts the required capacity for proper device function and reduces device longevity. there have been seven (7) reports worldwide of lost telemetry and pacing output as a result of a battery malfunction. battery malfunction may be indicated with a loss of telemetry/communication with the implanted device and/or loss of pacing and magnet mode operation. these events occurred between 29 and 37 months post implant. no patient injuries have been reported in association with the loss of bradycardia pacing therapy.
  • Action
    St Jude Medical has contacted the cardiologists who have implanted Nanostim leadless cardiac pacemakers providing further information about the above issue including patient management recommendations. They have been instructed to stop implanting these devices into new patients. For more information, please refer to https://www.tga.gov.au/alert/nanostim-leadless-cardiac-pacemaker . This action has been closed-out on 15/05/2017

Device

Nanostim Leadless Cardiac Pacemaker (LCP)
  • Model / Serial
    Nanostim Leadless Cardiac Pacemaker (LCP)Model Number: S1DLCP Supplied in Australia under Clinical Trial Notification (CTN) scheme
  • 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