TPLC - Total Product Life Cycle

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Device	transcranial magnetic stimulator
Definition	A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.
Product Code	OBP
Regulation Number	882.5805
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	79	79
Insufficient Information	34	34
Patient-Device Incompatibility	25	25
Patient Device Interaction Problem	9	9
Improper or Incorrect Procedure or Method	6	6
Output Problem	4	4
Unexpected Therapeutic Results	3	3
Energy Output Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Product Quality Problem	2	2
Device Operates Differently Than Expected	2	2
Appropriate Term/Code Not Available	2	2
Inadequate Instructions for Non-Healthcare Professional	1	1
Off-Label Use	1	1
Malposition of Device	1	1
Device Alarm System	1	1
Unintended Electrical Shock	1	1
Smoking	1	1
Output above Specifications	1	1
Use of Device Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Defibrillation/Stimulation Problem	1	1
Loose or Intermittent Connection	1	1
Loss of Power	1	1
Device Displays Incorrect Message	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Anxiety	58	58
Headache	53	53
Depression	44	44
Tinnitus	37	37
Pain	36	36
Sleep Dysfunction	31	31
Suicidal Ideation	28	28
Cognitive Changes	28	28
Convulsion/Seizure	26	26
Emotional Changes	25	25
Dizziness	20	20
Memory Loss/Impairment	18	18
Nausea	15	15
Fatigue	14	14
Twitching	10	10
Irritability	9	9
Hearing Impairment	8	8
Confusion/ Disorientation	8	8
Seizures	8	8
Vertigo	7	7
Brain Injury	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Weight Changes	7	7
Speech Disorder	5	5
Unspecified Eye / Vision Problem	5	5
Loss of consciousness	5	5
Unspecified Mental, Emotional or Behavioural Problem	5	5
Decreased Appetite	4	4
Increased Sensitivity	4	4
Complaint, Ill-Defined	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Hypersensitivity/Allergic reaction	4	4
Blurred Vision	4	4
Numbness	3	3
Lethargy	3	3
Ambulation Difficulties	3	3
Retinal Tear	3	3
Visual Impairment	3	3
Balance Problems	3	3
High Blood Pressure/ Hypertension	3	3
Therapeutic Response, Decreased	3	3
Palpitations	3	3
Visual Disturbances	3	3
Discomfort	2	2
Vomiting	2	2
Hair Loss	2	2
Bradycardia	2	2
Diarrhea	2	2
Undesired Nerve Stimulation	2	2
Ptosis	2	2