Events

Safety Alert for Emblem S-ICD 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
    2017-07-03
  • Event Date Posted
    2017-07-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170703.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 emblem s-icd system medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its emblem s-icd system [models: 1010, a209, a219]. the manufacturer informed physicians that a single and isolated s-icd event that resulted in a device-related patient death in may of 2017. the manufacturer’s engineers have determined that the 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. the repeated atypical energy delivery prevented s-icd arrhythmia detection/treatment and ultimately contributed to the patient death. according to the manufacturer, this experience represents one observed event in approximately 37,000 s-icds distributed worldwide. given the rarity of this single event observed to date, a precise projection of occurrence cannot be derived with confidence. engineering analysis of s-icd device memory design and recorded instances of single event upsets (seus) in fielded devices was conducted during the manufacturer’s root cause investigation of this event. based on this analysis, the probability of corruption of the specific location in memory that produces this device behavior within an s-icd was determined to be approximately 1 in 300,000 over five years. although reoccurrence of this device behavior is highly unlikely, the manufacturer is developing software mitigations to prevent this from occurring in the future. it is important to note that this particular device behavior cannot occur with any boston scientific transvenous defibrillators or pacemakers due to differences in hardware and software. until the software mitigation update is available, this s-icd behavior represents an additional, small risk that should be considered when evaluating the relative risks associated with all available icd therapy options. the manufacturer recommends the additional precautions listed in fsn. 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 necessary actions. posted on 3 july 2017.

Device

Emblem S-ICD System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Emblem S-ICD 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