TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
3	2	7	5	5	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	559	559
Adverse Event Without Identified Device or Use Problem	451	451
Insufficient Information	403	403
Off-Label Use	38	38
Overheating of Device	8	8
Patient Device Interaction Problem	7	7
Unintended Electrical Shock	3	3
Output Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Component Incompatible	2	2
Device-Device Incompatibility	2	2
Measurement System Incompatibility	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Unexpected Therapeutic Results	1	1
Inadequate or Insufficient Training	1	1
Use of Device Problem	1	1
Defective Component	1	1
Fluid/Blood Leak	1	1
Battery Problem	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	514	514
Skin Inflammation/ Irritation	282	282
Blister	82	82
Rash	79	79
Itching Sensation	78	78
Burning Sensation	45	45
Swelling/ Edema	44	44
Skin Irritation	44	44
Burn(s)	42	42
Hypersensitivity/Allergic reaction	30	30
Headache	29	29
Cramp(s) /Muscle Spasm(s)	26	26
Shock	24	24
Discomfort	20	20
Numbness	18	18
Paresthesia	15	15
Unspecified Infection	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Bruise/Contusion	11	11
Nausea	10	10
Swelling	9	9
Dizziness	9	9
Neuropathy	7	7
Erythema	6	6
High Blood Pressure/ Hypertension	6	6
Skin Burning Sensation	5	5
Irritability	5	5
Muscle Weakness	4	4
Skin Discoloration	4	4
Pressure Sores	4	4
Wheal(s)	4	4
Chest Pain	3	3
Diarrhea	3	3
Abrasion	3	3
Ambulation Difficulties	3	3
Neck Pain	3	3
Non-union Bone Fracture	3	3
Unspecified Heart Problem	3	3
Inflammation	3	3
No Code Available	3	3
Tachycardia	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Neuralgia	2	2
Convulsion/Seizure	2	2
Hemorrhage/Bleeding	2	2
Fungal Infection	2	2
Lethargy	2	2
Skin Infection	2	2
Neck Stiffness	2	2
Diaphoresis	2	2