TPLC - Total Product Life Cycle

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Device	stimulator, bone growth, non-invasive
Product Code	LOF
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
2	7	5	5	2	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	517	518
Adverse Event Without Identified Device or Use Problem	472	472
Insufficient Information	340	340
Off-Label Use	23	23
Patient Device Interaction Problem	7	7
Unintended Electrical Shock	3	3
Overheating of Device	3	3
Device-Device Incompatibility	2	2
Output Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Component Incompatible	2	2
Unintended Movement	1	1
Defective Component	1	1
Measurement System Incompatibility	1	1
Use of Device Problem	1	1
Unexpected Therapeutic Results	1	1
Inadequate or Insufficient Training	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	504	504
Skin Inflammation/ Irritation	273	273
Blister	84	84
Rash	78	79
Itching Sensation	76	77
Burn(s)	44	44
Swelling/ Edema	43	43
Hypersensitivity/Allergic reaction	31	32
Headache	30	30
Burning Sensation	29	29
Cramp(s) /Muscle Spasm(s)	29	29
Shock	22	22
Discomfort	20	20
Numbness	19	19
Paresthesia	15	15
Unspecified Infection	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Dizziness	9	9
Neuropathy	8	8
Nausea	8	8
High Blood Pressure/ Hypertension	7	7
Skin Burning Sensation	7	7
Erythema	6	7
Bruise/Contusion	5	5
Irritability	5	5
Chest Pain	4	4
Pressure Sores	4	4
Skin Discoloration	4	4
Muscle Weakness	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Abrasion	3	3
Inflammation	3	3
Neck Pain	3	3
Convulsion/Seizure	3	3
Diarrhea	3	3
Unspecified Heart Problem	3	3
Tachycardia	3	3
Non-union Bone Fracture	3	3
Loss of consciousness	2	2
Purulent Discharge	2	2
Hemorrhage/Bleeding	2	2
Fatigue	2	2
Bacterial Infection	2	2
Diaphoresis	2	2
Fungal Infection	2	2
Vertigo	2	2
Arrhythmia	2	2
Electric Shock	2	2
Lethargy	2	2
Insufficient Information	2	2