Events

Safety Alert for INLIVEN Cardiac Resynchronization Therapy 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
    2015-09-23
  • Event Date Posted
    2015-09-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150923a.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 inliven cardiac resynchronization therapy pacemakers medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its inliven cardiac resynchronization therapy pacemakers (crt-ps) [model w275]. according to the manufacturer, fifty-five (55) model w275 inliventm cardiac resynchronization therapy pacemakers (crt-ps) distributed by boston scientific in france and the czech republic are affected. label diagrams on the outer box and inner tray packaging of affected devices incorrectly describe the location of the lead ports on the device header. the correct lead port locations are etched on the case of the pacemaker and are visible at implant. the physician technical manual is also correct. if a pacing lead were to be inserted into the incorrect header port, inappropriate pacing could lead to loss of av or rv/lv synchrony, possibly with worsening heart failure until corrected. inappropriate pacing can be detected through standard device testing by evaluating either the intracardiac or surface electrocardiograms (ecg). the manufacturer advises affected users to take the following actions:- ensure that pacing leads are inserted into the correct lead ports. verify that all pacing leads are connected to the correct ports, either by reviewing device operation on intracardiac or ecg strips in medical records from a previous visit or by patient follow-up. according to the local supplier, the affected batch of products is not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.

Device

INLIVEN Cardiac Resynchronization Therapy Pacemakers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific INLIVEN Cardiac Resynchronization Therapy 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