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.