Events

Safety Alert for subcutaneous implantable defibrillator system

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

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
    2013-03-12
  • Event Date Posted
    2013-03-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130312.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: boston scientific subcutaneous implantable defibrillator system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the subcutaneous implantable defibrillator system, manufactured by boston scientific. according to the manufacturer, a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. the fuse has been unintentionally activated once during an implant procedure and three times post-implant out of approximately 1,900 devices implanted worldwide. all three post-implant events occurred within one month of implant. the defibrillator may not be able to deliver therapy or communicate with the q-tech model 2020 programmer, and may be unable to emit tones or otherwise respond to magnet application. no patient deaths or injuries have been reported as a result of this behavior. a non-invasive, software-based mitigation (version 1.95.0) has been developed to protect the fuse from unintended activation. local sales representative will install this new software on all q-tech model 2020 programmers located at the hospital/clinic. furthermore, the manufacturer has the following recommendations for healthcare professionals: for patients whose device has been implanted for less than three months, it is recommended to schedule a follow-up visit as soon as possible within the next six weeks for patients whose device has been implanted for three months or more, ensure the next scheduled visit occurs within three months of the previous visit, as recommended in device labeling at the next follow-up visit, interrogate each patient’s device using a programmer with version 1.95.0 software. interrogation with an updated programmer will automatically add the new software to the implanted device. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con244550 if you are in possession of the product, please contact your supplier for necessary actions. posted on 12 march 2013.

Device

subcutaneous implantable defibrillator system
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific subcutaneous implantable defibrillator system
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    DH