Events

Safety Alert for Convert+ Model V-195 Implantable Cardioverter-Defibrillator (ICD)

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
    2010-05-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20100507.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
    Press release
  • Reason
    Software defect causes malfunction in implantable cardioverter-defibrillator the department of health (dh) today (may 6) received notification from st. jude medical (hong kong) ltd., a local branch of a multi-national company, about a software problem in its convert+ model v-195 implantable cardioverter-defibrillator (icd). the model, if programmed by a merlin pcs programmer running version 7.2.1, version 8.2.1 or version 10.2.0 software, may not deliver therapy under certain circumstances. the defect can be corrected. st jude medical recommends doctors who have programmed a patient's device with any of the affected software versions should schedule a follow-up visit to perform the correction recommended by it. according to st. jude medical (hong kong) ltd., one patient has been implanted with this model of icd in hong kong. however, the implanted device has not been programmed with the affected software version. this model of icd ceased to be sold by the company in hong kong since mid-2007. no patient injury or death has been reported worldwide. patients may call st. jude medical (hong kong) ltd. at 9682 0488 for further details. a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell. meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with st. jude medical (hong kong) ltd. on further development, if any. end/thursday, may 6, 2010.

Device

Convert+ Model V-195 Implantable Cardioverter-Defibrillator (ICD)
  • Model / Serial
  • Product Description
    Press release: Software defect causes malfunction in implantable cardioverter-defibrillator
  • 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