Events

Recall of St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0 Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families

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-2014-RN-00034-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00034-1
  • 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
    When using the merlin programmer with software version17.2.2 as part of a single vf detection zone configuration for icd/crt-d devices, the sinus redetection value will be inappropriately set to zero milliseconds. as a result, any intrinsic activity following the first shock will be considered a “sinus rate” and the device will diagnose “return to sinus”. therefore, if the arrhythmia was not terminated by the initial high voltage therapy, the ongoing arrhythmia would be considered a new episode causing the next high voltage therapy to also be delivered at the first programmed energy level. for example, if the first shock is programmed to 20 joules and subsequent shocks are programmed to higher energy values, the only hv therapy the patient would receive if the arrhythmia continues and is redetected, would be 20 joules, rather than the increasing hv energy levels as programmed.
  • Action
    Clinicians are advised to review their SJM ICD/CRT-D patient records for patients with affected devices implanted or seen in clinic starting in September 2013 and programmed to a single VF detection zone with the 17.2.2 software. For patients identified during this review St. Jude is recommending to immediately schedule a follow-up visit. For patient devices programmed with 17.2.2 software, a new software version 17.2.3 will correct this issue and is expected to be available by February 2014. Using this software, programming any parameter will reset the return to sinus criteria to normal function. If a patient is seen before the 17.2.3 software is installed, then program the device to a two or three zone configuration, even if one of the zones is strictly a monitor zone. This will resolve the issue when using a programmer with 17.2.2 software. For more details, please see http://www.tga.gov.au/safety/alerts-device-st-jude-medical-icd-crtd-140128.htm . This action has been closed-out on 29/01/2016.

Device

St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programme...
  • Model / Serial
    St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families Multiple ARTG numbers for ICD/CRT-D devicesARTG number for the Merlin Programmer: 124262
  • 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