TPLC - Total Product Life Cycle

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Device	device, electroconvulsive therapy
Regulation Description	Electroconvulsive therapy device.
Product Code	GXC
Regulation Number	882.5940
Device Class	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Apparent Adverse Event	7	7
Patient-Device Incompatibility	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Memory Loss/Impairment	29	29
Cognitive Changes	18	18
Emotional Changes	11	11
Brain Injury	9	9
Suicidal Ideation	8	8
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	7	7
Depression	7	7
Anxiety	6	6
Sleep Dysfunction	6	6
Unspecified Mental, Emotional or Behavioural Problem	5	5
Confusion/ Disorientation	5	5
Intracranial Pressure Increased	4	4
Convulsion/Seizure	4	4
Asystole	3	3
Pain	3	3
Insufficient Information	3	3
Hemorrhagic Stroke	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Hematoma	2	2
Hyperresponsive to stimuli	2	2
Irritability	2	2
Status Epilepticus	2	2
Cardiac Arrest	2	2
Electrolyte Imbalance	2	2
Headache	2	2
Fatigue	2	2
Speech Disorder	2	2
Nerve Damage	2	2
Arrhythmia	2	2
Hyperventilation	2	2
Dysphasia	2	2
Muscle Weakness/Atrophy	2	2
Shaking/Tremors	2	2
Pulmonary Edema	2	2
Hormonal Imbalance	1	1
Heart Block	1	1
Sensitivity of Teeth	1	1
Cardiac Enzyme Elevation	1	1
Myocardial Infarction	1	1
Increased Sensitivity	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1
ST Segment Depression	1	1
Tachycardia	1	1
Aspiration Pneumonitis	1	1
Bradycardia	1	1
Lactate Dehydrogenase Increased	1	1
Coma	1	1
Visual Impairment	1	1
Laceration(s)	1	1