FOI release

RE Consulting data submitted to MORE

Case reference FOI2026/00658

Received 28 April 2026

Published 17 August 2026

Request

We've prepared a short overview below. We welcome your guidance on what would be considered in scope for a FoI. Devices in scope 1. Cardiac implants: pacemakers, implantable cardioverter defibrillators, cardiac resynchronisation therapy devices (including relevant subtypes where applicable),... 2. Neural implants: deep brain stimulation systems and spinal cord stimulation and neuromodulation systems, ... Primary request: anonymized case-level dataset We are looking for anonymized, case-level extracts from vigilance (post-market serious incident) reports for the device categories above, covering 1 January 2000 to present. If that full period is not feasible, please could you let us know what is the longest period that is feasible? Fields of interest (please could you indicate which represent data that is available): • Event date and/or date received by MORE - MHRA • Number of adverse event reports for selected AIMDs, identified by relevant GMDN codes • Device category (pacemaker / implantable cardioverter defibrillator / cardiac resynchronisation therapy device / deep brain stimulation system / spinal cord stimulation system) and device type/model fields if recorded • IMDRF annex breakdown for device problem and clinical symptoms as MHRA • Event type and seriousness • Problem / failure codes (or equivalent structured categories) • Patient sex (female/male/unknown, as recorded) • Patient age (preferably as bands) • Outcome and/or revision/explant/replacement indicator • Link to a Field Safety Corrective Action / Field Safety Notice (if recorded) • If available, any denominator/exposure proxy by sex • Any additional structured fields that are routinely available and relevant to interpreting the report Optional cross-tabulations (if feasible within FoI aggregation constraints) • year × device category × event type/seriousness × patient sex • if available: problem/failure code (or high-level failure mode) × device category × patient sex • optionally: age band × device category × patient sex • optionally: linkage to Field Safety Corrective Actions / Field Safety Notices • Sex × device category (GMDN) × severity • Sex × device issue category • Sex × clinical outcome category Finally, a simple pragmatic question, would you be providing the information as CSV or Excel (or another machine-readable format)? I look forward to your response and working with you to develop a FoI request that supports the progress of our research, whilst not excessively burdening your team. I hope that this work may even feed into your own internal reflection as to what data may, in the future, be made accessible through published summaries.

Response

See attached

Documents

• Annex 1 Neural Implants.pdf (1.2 MB)
• Annex 2 Cardiac Implants Pacemaker.pdf (8.4 MB)
• Annex 3 Implantable Cardioverter defibrillators.pdf (6.7 MB)
• Annex 4 Cardiac resynchronisation therapy devices-LAPT22410.pdf (4.0 MB)
• FOI2026_00658 (redacted).pdf (1.6 MB)

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