Guidance

Device-specific vigilance guidance: neurostimulators

Updated 15 January 2025

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This publication is available at /government/publications/reporting-adverse-incidents-neurostimulators/device-specific-vigilance-guidance-neurostimulators

滨苍迟谤辞诲耻肠迟颈辞苍听听

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.听听

The aim of this guidance is to complement the requirements of and should be read in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.听听聽

What to report聽

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.聽

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

  • telemetry failure (during or after implantation)聽

  • fracture of accessory or introducer items聽

  • premature battery depletion聽

  • inability of rechargeable battery to hold charge聽

  • mechanical failure of pulse generator (including internal components)聽

  • electrical failure of pulse generator聽

  • unexplained loss of therapy聽

  • 苍别耻谤辞辫谤补虫颈补听

  • tissue damage聽

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

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

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

  • lead fracture 聽

  • lead shorts 聽

  • lead migration 聽

  • high lead impedance 聽

  • electromagnetic interference 聽

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

  • a change in stimulation due to fibrosis around electrode
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