Events

Recall of Emblem and SQ-RX Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific 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-2017-RN-00830-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00830-1
  • 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
    Boston scientific has been informed of a single, isolated s-icd event that resulted in a device-related patient death in may of 2017. boston scientific engineers have determined that this patient’s s-icd repeatedly delivered an atypical amount of energy (similar to the arrhythmia induction function) because a specific memory location was corrupted by radiation within the environment. this repeated atypical energy delivery prevented s-icd arrhythmia detection/treatment and ultimately contributed to the patient death. this device behaviour has been simulated in a laboratory setting by corrupting two specific adjacent bits of device memory on similar model s-icds, and the test results correlated with the information available from this event. although this device behaviour is highly unlikely to reoccur, an s-icd software update is being developed to mitigate the effects of memory corruption by preventing atypical energy delivery.
  • Action
    Boston Scientific are developing a software update (v4.04 or higher) that addresses the behaviour. In the interim, Boston Scientific recommends NO changes to clinical follow-up due to this single event. Specifically, for patients with S-ICD systems: 1. Continue using the S-ICD system to detect and treat life-threatening ventricular tachyarrhythmias; 2. Keep scheduled LATITUDE and/or in clinic follow-ups; and 3. Follow the precautions identified in the S-ICD user’s manual when radiation therapy is prescribed. Furthermore, Boston Scientific does NOT recommend the following: 4. Early or off-cycle follow-ups are not recommended. This type of memory corruption cannot be detected, thus additional S-ICD checks do not reduce the potential for this device behaviour. 5. Prophylactic S-ICD replacement or explant is not recommended. The risks associated with such an additional surgical procedure significantly outweigh the risk of reoccurrence of this device behaviour.

Device

Emblem and SQ-RX Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)
  • Model / Serial
    Emblem and SQ-RX Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)Emblem S-ICDsModel Numbers: A209 and A219SQ-RX S-ICDModel Number: 1010ARTG Numbers: 260382, 286705 & 219499
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA