Table. Adverse events during magnetic resonance imaging examinations.
Description | Generator | Lead(s), lead tip position | Examined anatomical region | max. SAR (Watt/kg) | Number of sequences |
Serious adverse events (n = 1) | |||||
Defective generator | EonC | Octrode, C3 | Hand | 2.2 | 10 |
Adverse events: device heating (n = 3) | |||||
Discontinued due to mild heating and panic attack | Eon | Octrode, T10 | Skull | 0.3 | 1 |
Discontinued due to heating along the lead | Genesis | Octrode, Tâ3 | Shoulder | 2.0 | 4 |
Generator heating | Genesis (discharged) | Lamitrode S-8, T7 | TSp/LSp | 4.0 | 8 |
Adverse events: undesired stimulation (n = 8) | |||||
Discontinued due to electrifying sensations | Eon mini | Octrode, T8 | LSp | 0.5 | 1 |
Discontinued due to electrifying sensations | Prodigy MRI | Octrode, T8 | LSp | n.s. | 0 |
Discontinued due to electrifying sensations | Eon mini | Lamitrode S-8, T7 | TSp/LSp | 0.5 | 1 |
Discontinued due to electrifying sensations* | Genesis | Lamitrode S-8, T8 | Shoulder | 3.8 | 9 |
Discontinued due to involuntary movements | Eon mini | Octrode, T7 Octrode, T8 (displaced ventrally) | TSp/LSp | 0.5 | 1 |
Discontinued due to involuntary movements | Genesis | Octrode, C3 | Shoulder | 0.3 | 1 |
Electrifying sensations after contrast agent infusion | Prodigy MRI | Octrode, T8Octrode, T9 | Foot | 4.0 | 10 |
Electrifying sensations after contrast agent infusion | Eon mini | Octrode, C2 | CSp | 4.0 | 7 |
Adverse events unrelated to neurostimulator (n = 2) | |||||
Discontinued due to position-related back pain* | Genesis | Lamitrode S-8, T8 | Shoulder | 3.8 | 6 |
Discontinued due to claustrophobia | Proclaim 5 Elite | Octrode, T8 | Skull | 0.6 | 2 |
There was no statistically significant correlation between complication rate and examined anatomical region. There was also no evidence for differences related to the number of examinations performed to date.
* One patient experienced discontinuation in each of two independently performed examinations. All other adverse events occurred in different patients. s
T, C, thoracic, cervical vertebra; TSp, CSp, LSp, thoracic, cervical, lumbar spine; n.s., not specified; SAR, specific absorption rate (measure of the energy absorbed by the body per unit of time, mostly six minutes).