Events

Field Safety Notices about Pulsante SPG Microstimulator System

According to Inspectie Gezondheidszorg en Jeugd, this field safety notices involved a device in Netherlands that was produced by Autonomic Technologies.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-04-07
  • Event Country
    Netherlands
  • Event Source
    IGJ
  • Event Source URL
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/04/7/field-safety-notice-autonomic-technologies---pulsante-spg-microstimulator-system
  • Notes / Alerts
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 recall data from the U.S. and the Netherlands.
  • Extra notes in the data
  • Reason
    A change was made to the pulsante® spg microstimulator (the implantable component) which was not properly validated. this change requires further validation to ensure patient safety.

Device

Pulsante SPG Microstimulator System

Manufacturer

Autonomic Technologies
  • Manufacturer Parent Company (2017)
    Autonomic Technologies Inc.
  • Manufacturer comment
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ