Events

Recall of Optisure Dual Coil Defibrillation Leads(Lead, defibrillator/pacemaker, implantable

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-2015-RN-01086-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01086-1
  • 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 has become aware of a small number of optisure dual coil defibrillation leads that may have had potential insulation damage at the interface of the termination sleeve and svc shock coil in optisure dual coil defibrillation leads. this damage has been determined to have occurred during the manufacturing process.In the event that a subject optisure lead is connected to a device without dynamic tx technology, there is the potential for lead damage to result in loss of defibrillation therapy during attempted shock delivery when programmed to the rv to svc and can high voltage therapy configurationst. jude medical is not aware of any complaints or clinical incidents related to this matter.
  • Action
    Customers are asked to quarantine all unused units prior to return to St Jude Medical. For affected units that have been implanted, St Jude Medical is advising that patients should continue to be managed in accordance with the patient management protocol included in the customer letter. For further information, please see http://www.tga.gov.au/alert/optisure-dual-coil-defibrillation-leads This action has been closed-out on 22/08/2016.

Device

Optisure Dual Coil Defibrillation Leads(Lead, defibrillator/pacemaker, implantable
  • Model / Serial
    Optisure Dual Coil Defibrillation Leads(Lead, defibrillator/pacemaker, implantable)Model Numbers: LDA220Q/52, LDA220Q/58, LDA220 Q/65 and LDP 220Q/58ARTG Numbers: 221010, 221013 and 221011
  • Product Classification
    Cardiovascular Devices
  • 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