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
Adverse Event Without Identified Device or Use Problem	25	25
Patient-Device Incompatibility	7	7
No Apparent Adverse Event	7	7
Inadequate Instructions for Non-Healthcare Professional	3	3
Patient Device Interaction Problem	2	2
Break	1	1
Output Problem	1	1
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inadequate Instructions for Healthcare Professional	1	1
Unexpected Therapeutic Results	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Memory Loss/Impairment	28	28
Cognitive Changes	18	18
Emotional Changes	8	8
Brain Injury	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Depression	7	7
Suicidal Ideation	7	7
Sleep Dysfunction	6	6
Confusion/ Disorientation	5	5
Unspecified Mental, Emotional or Behavioural Problem	5	5
Anxiety	4	4
No Clinical Signs, Symptoms or Conditions	3	3
Insufficient Information	3	3
Pain	3	3
Increased Sensitivity	2	2
Dysphasia	2	2
Status Epilepticus	2	2
Irritability	2	2
Headache	2	2
Convulsion/Seizure	2	2
Shaking/Tremors	2	2
Nerve Damage	2	2
Aspiration Pneumonitis	1	1
ST Segment Depression	1	1
Increased Sensitivity	1	1
Sensitivity of Teeth	1	1
Hormonal Imbalance	1	1
Heart Block	1	1
Cardiac Enzyme Elevation	1	1
Myocardial Infarction	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1
Tachycardia	1	1
Asystole	1	1
Bradycardia	1	1
Lactate Dehydrogenase Increased	1	1
Coma	1	1
Visual Impairment	1	1
Laceration(s)	1	1
Dyspnea	1	1
Alteration in Body Temperature	1	1
Chest Pain	1	1
Thrombosis/Thrombus	1	1
Visual Disturbances	1	1
Movement Disorder	1	1
Hemorrhagic Stroke	1	1
Obstruction/Occlusion	1	1
Atrial Fibrillation	1	1
Diminished Pulse Pressure	1	1
Ischemia	1	1