Events

Safety Alert for SonRtip endocardial pacing lead with contractility sensor, model PS55D

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

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
    2012-02-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120228b.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: sonrtip endocardial pacing lead with contractility sensor, model ps55d the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning sonrtip endocardial pacing lead with contractility sensor, model ps55d. the manufacturer of the device, sorin crm, has received two reports in post-market surveillance that part or all of the fixation helix of the sonrtip lead remained in the myocardium after the lead had been removed. no permanent injury or death has occurred. investigation by the manufacturer revealed that an excessive number of turns has been applied to the lead during fixation. according to the local supplier, the affected product is not distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

SonRtip endocardial pacing lead with contractility sensor, model PS55D
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SonRtip endocardial pacing lead with contractility sensor, model PS55D
  • Manufacturer
    Sorin CRM

Manufacturer

Sorin CRM