Guidance

Device-specific vigilance guidance: neurostimulators

Updated 15 January 2025

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This publication is available at https://www.gov.uk/government/publications/reporting-adverse-incidents-neurostimulators/device-specific-vigilance-guidance-neurostimulators

Introduction  

This document provides guidance for manufacturers of neurostimulators. It outlines specific scenarios to consider when determining if an incident is reportable. You should read this document in conjunction with guidance on post-market surveillance.  

The aim of this guidance is to complement the requirements of SI 2024 No. 1368 and should be read in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.   

What to report 

The following examples indicate how to report device performance problems associated with neurostimulators that caused or contributed to an incident. The examples are for illustrative purposes only and do not constitute an exhaustive list. If an incident appears to meet criteria contained in more than one category, ensure it is included in submissions under each reporting format, even if this results in duplication of reporting for that incident. 

1. Report as individual events (in line with statutory timescales):

  • telemetry failure (during or after implantation) 

  • fracture of accessory or introducer items 

  • premature battery depletion 

  • inability of rechargeable battery to hold charge 

  • mechanical failure of pulse generator (including internal components) 

  • electrical failure of pulse generator 

  • unexplained loss of therapy 

  • neuropraxia 

  • tissue damage 

2. Incidents that may be included in periodic summary reports (PSR) on agreement 

If you cannot use PSR, then report these events individually. 

You should report the following on a 3-monthly basis (or as agreed): 

  • lead fracture  

  • lead shorts  

  • lead migration  

  • high lead impedance  

  • electromagnetic interference  

3. Report at the time of a significant increase in the frequency or severity of incidents: 

  • a change in stimulation due to fibrosis around electrode
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