VNS Therapy · Forms · Complaint

Complaint registration

Use this form to register any complaint related to VNS Therapy: the product, the therapy, or any other concern you encounter.

Moving to the GNM Hub on 1 January 2027

Please file complaints in the GNM Hub instead.

The GNM Hub is our signed-in space for healthcare professionals. It is the better way to file a complaint:

  • Less typing. Your name, contact details, hospital and department are filled in for you.
  • A record you can see. You can look back at every complaint you have filed, with its reference and status.
  • Secure. Access is approved person by person, sign-in takes two steps, and what you send, including pictures and documents, is stored in the EU and handled under documented procedures.

This open form will be closed on 1 January 2027. From that date, complaints can only be filed in the Hub. Requesting access takes a couple of minutes, so please do it now.

Complaints are registered in line with the EU Medical Device Regulation (MDR). Go North Medical records each report and forwards it to the manufacturer, who handles it under its complaint procedure.

About you

We send the confirmation here. If you later create a GNM Hub account with this address, your earlier complaints will appear there.
Title

Hospital

Department

Product

Which product is the complaint about?
Generator model

What happened

Do not include the patient's name, initials, personal identity number or date of birth. Describe the event and the clinical details needed to understand it, nothing that identifies the patient.
Describe the issue (malfunction, failure, adverse event) and the circumstances. Include symptoms and complications, if any.
Side effects, adverse events, changes in the perception of stimulation, re-emergence of symptoms, or changes in clinical outcome due to the issue.
For example reprogramming, reducing output current, or replacing the generator.
Optional. A damaged tablet or wand needs a picture of the damage. Up to 5 files, JPG, PNG, HEIC or PDF, 10 MB each and 15 MB in total. Make sure no patient name or identity number is visible, for example on a programmer screen.

Handling of a replaced unit

If a unit is replaced, how will the damaged or faulty unit be handled?

Reports are forwarded to the manufacturer and kept for 15 years, as described in our privacy notice. Filing a report with Go North Medical does not replace your hospital's own duty to report serious incidents to the national authority.

* Required fields. Urgent safety concern? Call your Go North Medical contact directly.

What happens next

  • You get an automatic confirmation with a reference.
  • We check the report, ask you for anything that is missing, and forward it to the manufacturer.
  • The manufacturer may contact you for more information.