Events

Safety Alert for Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by St Jude Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-10-11
  • Event Date Posted
    2016-10-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161011a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: st. jude medical implantable devices- fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra medical device manufacturer, st jude medical, has issued a medical device safety alert concerning its implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds) manufactured before may 2015. the affected models are fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra. according to the manufacturer, among 398,740 devices sold worldwide, 841 devices returned for analysis due to premature battery depletion have had evidence of lithium material in the form of “clusters” in the battery. forty-six exhibited visible clusters bridging the cathode and anode causing shorting. lithium cluster formation is a known phenomenon with this type of battery. the manufacturer is contacting physicians to provide details regarding risk and patient management recommendations because premature battery depletion has been observed to occur within days. there have been two deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion. high voltage devices (icds and crt-ds) that utilize lithium-based battery chemistries are subject to lithium cluster formation during high voltage charging. depending on their location, lithium clusters may cause a short circuit that can lead to premature battery depletion. the manufacturer’s investigation indicates that if a short circuit occurs, battery depletion can occur in these devices within a day to a few weeks, which may result in the inability to deliver therapy. premature battery depletion can be identified by physicians through home monitoring or in person visits showing elective replacement indicator (eri) or more advanced battery depletion. patients may become aware when their device reaches eri because they may feel a vibratory patient notifier alert. patients who cannot feel the vibratory alert may not know their device has reached eri. therefore, the manufacturer has provided recommendations below that include confirming patients can feel and recognize vibratory alerts and reaffirming the availability and usage of home monitoring to avoid or minimize time without device therapy for bradycardia and tachycardia events. the manufacturer provided physicians with the following patient management recommendations: do not implant unused affected devices. conduct patient follow-up per standard practice. prophylactic device replacement is not recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion due to lithium cluster induced shorts. in the event of an eri indicator in these devices, immediate device change is recommended. at this time there is no factor, method or test to identify devices with this form of premature battery depletion approaching eri or to accurately predict remaining battery life once eri appears. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for further patient management recommendations and other necessary actions. posted on 11 october 2016.

Device

Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: St. Jude Medical Implantable devices- Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • 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
    DH