Events

Safety Alert for Accolade family pacemakers

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
    2018-08-24
  • Event Date Posted
    2018-08-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180824b.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 accolade family pacemakers medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its accolade family pacemakers, the devices are identified as follow: product: a) single chamber pacemakers; b) dual chamber pacemakers; c) cardiac resynchronization therapy pacemakers (crt-ps) model: a) l200 proponent pacemakers, s701 altrua 2 pacemakers; b) l121 essentio pacemakers, s702 altrua 2 pacemakers, s722 altrua 2 pacemakers; c) u128 valitude crt-p during a review of warehouse inventory, a discrepancy was identified between the box/tray label and the nominal device values shown on the programmer screen(s) for an accolade family pacemaker. further investigation identified the following errors on box and tray labels for certain accolade family pacemakers and crt-ps: for single chamber, dual chamber and crt-p models, the box and tray labels for nominal ventricular amplitude reads (3.5mv). the correct value is (3.5v); for single chamber models, the box and tray labels include a value for paced av delay and sensed av delay. they should not be included on the labels, as they do not apply for single chamber devices; for single chanber models, the box and tray labels for the ventricular refractory rv (max/min) read 250ms/230ms. the correct value is 250ms/250ms. the manufacturer has determined that this is a box and tray labeling discrepancy and has no impact on device or programmer performance. the nominal parameters printed on the table are not options available for programming by the user when the device is programmed in vvi mode (at nominal settings). there is no foreseeable risk to patient safety. the affected inventory may be safely implanted and used with the accompanying documentation. according to the local supplier, the affected box and tray labels are only on product distributed in china. accolade pacemakers and crt-ps distributed to other countries do not include the affected nominal settings table on the box/tray. there is no affected customer in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 august 2018.

Device

Accolade family pacemakers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Accolade family pacemakers
  • 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