Table 1

Suggested consent statement for implanting cardiologists when potentially implanting an MR Unlabelled device, or revising/upgrading a device that may then become MR Unlabelled (such as upgrading a pacemaker to a CRT using a lead from a different manufacturer to the existing leads and generator)

Implanting an MR Unlabelled CIED or revising an existing device such that the MR conditions cannot be met.
There may be a need to implant or upgrade your pacemaker/defibrillator with a device system that has not been formally approved to undergo MRI scanning by the manufacturer.
This means that it may be more difficult for you to have an MRI scan in the future should you need one. Although almost all devices can be scanned, these are generally only done in specialist centres.
A decision to go ahead with a MRI scan may be made after discussing the possible benefits, risks and alternatives with your referring doctor at such a time an MRI is requested.
Serious complications related to MRI occur in <1 in every 2000 patients (about 0.05%) with these devices if there are no other high-risk features. These include, but are not limited to:
  • damage to the cardiac device;

  • abnormal heart rhythms;

  • excessive tissue heating.

  • CIED, cardiac implantable electronic device; CRT, cardiac resynchronisation therapy.