FOI release
Freedom of Information Request – Nevro HFX/Senza Spinal Cord Stimulator Adverse Incidents
Case reference FOI2026/00861
Received 4 August 2026
Published 14 September 2026
Request
I am making a request under the Freedom of Information Act 2000 concerning adverse incident reports involving Nevro spinal cord stimulation systems in the United Kingdom. Please provide information held by the MHRA for the period 1 January 2020 to the date of this request concerning medical-device adverse incident reports relating to: • Nevro HFX • Nevro Senza • Senza II • Senza Omnia / Omnia • Nevro implantable pulse generators (IPGs), particularly model NIPG2500 I would specifically like to know: 1. The total number of UK adverse incident reports received concerning these devices, broken down by calendar year where possible. 2. Where recorded, the number of reports involving any of the following: • electric shock or electric-shock-like sensations • unintended or abnormal stimulation • overstimulation • muscle spasms, contractions or involuntary movements • burning sensations • heating or abnormal warmth around the implanted IPG • pain at or around the IPG/battery pocket • pain along the lead or IPG-to-lead pathway • battery or IPG malfunction • charging problems • abnormal electrode/contact impedance • lead or connector malfunction • device or IPG migration 1. Where recorded, the number of incidents in which symptoms were reported to stop, substantially improve or otherwise change when stimulation was switched OFF. 2. The number of reported incidents resulting in: • revision surgery • replacement of the IPG/generator • replacement of leads • complete explantation of the spinal cord stimulation system • serious injury • death 1. Specifically for the Nevro NIPG2500, please provide the number of adverse incident reports involving this model and, where possible, the reported event/problem categories and outcomes. 2. Where disclosure is permitted, please provide anonymised incident narratives or summaries for reports involving electric-shock sensations, abnormal stimulation, muscle spasms/contractions, burning/heating or pain associated with the IPG. I am not requesting any patient-identifiable information. If providing individual incident narratives would engage an exemption or cause this request to exceed the appropriate cost limit, please provide the requested numerical/aggregated information and event categories instead. If any part of this request is considered too broad to process within the statutory cost limit, I would be grateful if you could provide advice and assistance under Section 16 of the Freedom of Information Act as to how I might narrow the request while retaining information specifically concerning NIPG2500/HFX adverse incidents. I would prefer the information electronically, ideally in spreadsheet or CSV format if the data are held in a structured database.
Response
See attached
Documents
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