Events

Safety Alert for APS III Model 3500/3510 programming devices (software versions 6.1.1 and earlier) and Merlin PCS Model 3650 programming devices (software versions 4.1.1 and earlier)

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

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
    2006-10-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20061019.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 problem found in programming devices for implantable pacemakers the department of health received notification from a medical device manufacturing company about a software problem in two programming devices used by doctors for checking the battery level of pacemakers. the programming devices concerned, produced by st. jude medical inc., are aps iii model 3500/3510 programming devices (software versions 6.1.1 and earlier) and merlin pcs model 3650 programming devices (software versions 4.1.1 and earlier). they are specially designed and made to measure the battery level of the following three pacemaker models manufactured by the same company - identity sr model 5172 identity dr model 5370 identity xl dr model 5376 a spokesman for dh said the software problem may lead to incorrect reporting of battery voltage, expected battery lifespan of the pacemakers and early replacement indicator in the devices. the details can be found at the corporate website of st. jude medical, inc. at www.Sjm.Com . dh has alerted the hospital authority, private hospitals and other relevant medical professional organisations of this safety information. no patient injury or death has been reported so far. the spokesman said patients shall call the hotlines of st. jude medical ( hong kong ) ltd at 2996 7688 from 9 am to 6 pm from monday to friday for enquiries. they can call 9666 4545 or 9777 0097 outside office hours. he reminded patients with these implanted pacemakers to attend scheduled regular check-ups arranged with their doctors. if they have any symptoms of heart disease, they should seek medical attention immediately. end/thursday, october 19, 2006 nnnn.

Device

APS III Model 3500/3510 programming devices (software versions 6.1.1 and earlier) and Merlin PCS ...
  • Model / Serial
  • Product Description
    Press release: Software Problem Found in Programming Devices for Implantable Pacemakers
  • Manufacturer
    St

Manufacturer

St
  • 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