Quality & complianceOfficial

Medtronic warns of incompatible InterStim SureScan MRI lead and extension selections, citing 15 complaints

🇳🇱 IGJ · Sun 01 Nov 2026

The Dutch inspectorate has published a manufacturer field safety notice dated 5 October 2026 on incompatible lead and percutaneous extension pairings in Medtronic's InterStim SureScan MRI system.

The Dutch healthcare inspectorate IGJ has published a Medtronic field safety notice (FSN) for InterStim SureScan MRI leads. The notice is dated 5 October 2026, and IGJ's webpage carries the date 2 November 2026. The accompanying PDF runs to six pages.

According to the text, Medtronic received 15 complaints between 1 January 2020 and 12 August 2026. Each involved the selection of an incompatible InterStim SureScan MRI lead (model 978B1 or 978A1) or percutaneous extension, based on the intended system configuration. The company puts the global incidence at 0.006%.

The extensions named are model 3560022, intended for the 978B1 lead, and model 3560030, intended for the 978A1 lead. The source says that using an incompatible lead or extension can stop the system working properly. The available text is cut off mid-sentence, but it states that this has led to delays to the procedure and, apparently, to the need for surgical replacement.

IGJ presents the item as a manufacturer warning. Under the regime it describes, manufacturers must monitor devices after they reach the market and take action where users are at risk. They inform users and the inspectorate of that action through an FSN. The available text does not set out the specific corrective actions Medtronic is asking users to take, so these should be checked in the full PDF.

What it means for your team

  • Device safety and QA teams at hospitals and distributors should read the full six-page FSN for the required actions, which are not in the available excerpt.
  • Check procedures for selecting and pairing leads and extensions: 978B1 goes with extension 3560022, and 978A1 with 3560030, as stated in the notice.
  • Manufacturers and vigilance teams can note the 15 complaints over 2020 to August 2026 as a case of a configuration or selection issue, rather than a fault in a single component.
  • Record the FSN date of 5 October 2026 in field action tracking systems.

Official source: IGJ ↗

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

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