Events

Safety Alert for Cardiac Resynchronization Therapy (CRT) pacemakers and defibrillators - CRT Positive Left Ventricular Offset

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
    2017-12-22
  • Event Date Posted
    2017-12-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171222b.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 cardiac resynchronization therapy (crt) pacemakers and defibrillators - crt positive left ventricular offset medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its cardiac resynchronization therapy pacemakers (crt-ps) and defibrillators (crt-ds). the affected crt devices are identified as the following:- valitude crt-p [models: u125 and u128] resonate crt-d [models: g424, g425, g426. g428, g437, g447, g448, g525, g526, g528, g537, g547, g548] momentum crt-d [models: g124, g125, g126, g128, g138] autogen crt-d [models: g160, g161, g166, g168, g172, g173, g175, g177, g179] inogen crt-d [models: g140, g141, g146, g148] visionist crt-p [models: u225, u226, u228] vigilant crt-d [models: g224, g225, g228, g237, g247, g248] charisma crt-d [models: g324, g325, g328, g337, g347, g348] dynagen crt-d [models: g150, g151, g156, g158] origen crt-d [models: g050, g051, g056, g058] the manufacturer has issued a field action product advisory to physician includes important programming information to prevent an unintended asynchronous biventricular (biv) pacing behavior when tracking elevated atrial intrinsic rhythms in certain crt-ps and crt-ds. according to the manufacturer, repeated detection of the unintended asynchronous biv pacing behavior may result in the implanted device reverting to a permanent safety mode (safety core) status thus requiring early replacement. the unintended asynchronous biv pacing behavior can only occur when an infrequent combination of parameters is programmed, specifically: left ventricular (lv) offset programmed to a positive value which exceeds the atrial blank after ventricular pace (a-blank after v-pace) interval; and tracking preference = on (nominal). until software is available to prevent programming of a susceptible combination of parameters, the advisory’s programming recommendations eliminate the risks associated with early device replacement due to the device behavior. crt devices more commonly programmed to simultaneous biv pacing (lv offset = zero) or sequential biv where lv precedes rv (negative lv offset value) are not subject to the risks described in the advisory the manufacturer is actively developing a software update designed to prevent programming of a susceptible combination of parameters. 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 22 december 2017.

Device

Cardiac Resynchronization Therapy (CRT) pacemakers and defibrillators - CRT Positive Left Ventric...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Cardiac Resynchronization Therapy (CRT) pacemakers and defibrillators - CRT Positive Left Ventricular Offset
  • 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