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Case Reports
. 2016 May 15;2(2):20150219.
doi: 10.1259/bjrcr.20150219. eCollection 2016.

Off-label MRI examination of an MR conditional pacemaker

Jonathon Delve  1 , Peter Wright  2 , Ashish Patwala  3 , Dipti Patel  4 , Matthew Stevenson  3
Affiliations
Case Reports

Off-label MRI examination of an MR conditional pacemaker

Jonathon Delve et al. BJR Case Rep. .

Abstract

An 18-year-old patient was implanted with an MR-conditional pacemaker using a lead plug which negated the manufacturer CE approved MR conditional status of the pacing system. The patient was referred for a lumbar spine MRI. The clinical opinion was that the risk of proceeding with the MRI was acceptable given the alternatives of: (a) changing the pacing system or (b) not performing the scan. A risk assessment revealed that the additional risk was very low and easily mitigated by an established technique. Informed consent was obtained and the scan was completed without incident following a slightly modified MR-conditional pacemaker scanning protocol.

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References

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    1. Medicines and Healthcare products Regulatory Agency, 2014 Guidance: off-label use of a medical device. London, UK: MHRA; [Accessed 23 March 2015]. Available from: https://www.gov.uk/government/publications/medical-devices-off-label-use

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