Thymatron
®
System IV Instructions for Use
10
SERIOUS ADVERSE EVENTS
Recent estimates in the medical literature of the mortality rate associated with ECT are 1 per 10,000 patients or 1
per 80,000 treatments.
Other serious adverse events have occurred, including adverse reaction to anesthetic agents / neuromuscular
blocking agents; adverse skin reactions (e.g., skin burns); cardiac complications, including arrhythmia,
ischemia/infarction (i.e., heart attack), acute hypertension, hypotension, and stroke; cognition and memory
impairment; brain injury; dental/oral trauma; general motor dysfunction; physical trauma (i.e., if inadequate
supportive drug treatment is provided to mitigate unconscious violent movements during convulsions) including
fractures, contusions, injury from falls, dental or oral injury; hypomanic or manic symptoms (e.g., treatment-
emergent mania, postictal delirium or excitement); neurological symptoms (e.g., paresthesia, dyskinesias);
tardive seizures; prolonged seizures; non-convulsive status epilepticus; pulmonary complications (e.g.,
aspiration/inhalation of foreign material, pneumonia, hypoxia, respiratory obstruction such as laryngospasm,
pulmonary embolism, prolonged apnea); visual disturbance; auditory complications; onset/exacerbation of
psychiatric symptoms; partial relief of depression enabling completed suicide; homicidality; substance abuse;
coma; falls; and device malfunction (creating potential risks such as excessive dose administration), and death.
Certain patients are more likely to experience severe adverse events, including those with pre-existing cardiac
illness, compromised pulmonary status, a history of brain injury, or medical complications after earlier courses
of anesthesia or ECT. Concurrent administration of antipsychotic (neuroleptic) medication may increase the risks
of adverse cardiac, pulmonary, and neurological events, and falls. Concurrent administration of stimulants may
increase the risks of cardiac and neurological complications, such as prolonged seizure. All of this information
should be assessed in developing the treatment plan for a particular patient.
OTHER RISKS
Completed suicide in ECT patients has a reported rate of 0.5 per 100 patient years, but higher in patients recently
discharged after hospitalization with suicidality. Studies have shown that partial improvement along the course
of ECT, before remission is obtained, can enable suicidal behavior or suicide in patients previously too ill to plan
or commit suicide. Likewise, suicide is a concern after ECT treatment; for instance, one study found that ECT
patients had a slightly higher suicide rate within seven days after their last ECT treatment than non-ECT
inpatients (Munk-Olsen et al., 2007). A meta-analysis found that 30% of patients with treatment-resistant
depression attempt suicide, with a rate for completed suicide of 0.47 per 100 patient years which included
similar incidence following DBS, VNS and ECT (Bergfeld et al., 2018).
ECT may result in worsening of an underlying medical condition either by: (1) ineffective treatment or (2) the
treatment itself, particularly when it exacerbates the symptoms.
