Quality & complianceOfficial

Dutch inspectorate publishes Boston Scientific field safety notice on Vercise Neural Navigator 5 software

🇳🇱 IGJ · Thu 12 Nov 2026

IGJ has posted a manufacturer warning on the Vercise Neural Navigator 5 software, centred on how an inaccurate battery estimate could lead to interrupted stimulation.

The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning from Boston Scientific Neuromodulation Corporation concerning its Vercise Neural Navigator 5 software. The notice is a field safety notice (FSN) dated 6 November 2026, and the IGJ listing carries a date of 13 November 2026. The PDF runs to seven pages. Boston Scientific Limited is named as the authorised representative.

The excerpt published by the inspectorate describes the risk pathway. An inaccurate battery estimate would only contribute to patient harm if it first influenced a clinician's battery management decisions. Examples given are planning the timing of IPG replacement or advising a patient on battery charging requirements.

If those decisions led to delayed battery replacement or insufficient charging, a subsequently depleted battery could interrupt stimulation, according to the text.

The excerpt does not say what corrective action the manufacturer is taking, which software versions or devices are affected, or what timelines apply. Those details are likely to sit in the full PDF notice, which was not available in the material reviewed.

The IGJ notes that manufacturers must monitor their devices after they reach the market and improve them where necessary. When a risk to users arises, the manufacturer must act and inform users and the inspectorate through a field safety notice.

What it means for your team

  • Teams supporting Vercise systems should obtain the full FSN to confirm affected software versions, required actions and deadlines, as the IGJ excerpt gives none of these.
  • Clinical and quality staff may wish to check whether battery-life estimates from the software feed into replacement scheduling or patient charging advice.
  • Vigilance teams should consider whether any reports of unexpected loss of stimulation or battery depletion relate to this issue and log them accordingly.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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