Events

Safety Alert for OPTIMIZER® III Implantable Pulse Generator

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

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
    2011-11-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111125.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
    Field safety notice: impulse dynamics optimizer® iii implantable pulse generator medical device manufacturer, impulse dynamics, has issued a field safety notice concerning optimizer® iii implantable pulse generator (ipg). impulse dynamics recently received four reports from germany concerning the optimizer iii ipg. one of the device components, the reed switch, became stuck during ipg recharge. when it became stuck the devices went into "magnet mode" which is a setting which automatically turns off cardiac contractility modulation therapy. this state can typically be changed to reinitiate therapy by reprogramming the optimizer® iii device with the omni programmer. however, a stuck reed switch affects the telemetry reception by the ipg, preventing reprogramming until the reed switch is released. the event does not present a significant risk to continued use of the device. according to innotronik hong kong limited, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

OPTIMIZER® III Implantable Pulse Generator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Impulse Dynamics OPTIMIZERR III Implantable Pulse Generator
  • Manufacturer
    Impulse Dynamics

Manufacturer

Impulse Dynamics