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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, low electric field, tumor treatment
Definition Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.
Product CodeNZK
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
3 2 1 4 1 1

MDR Year MDR Reports MDR Events
2018 23 23
2019 21 21
2020 30 30
2021 32 32
2022 26 26
2023 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 155 155
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 71 71
Post Operative Wound Infection 57 57
Ulcer 17 17
Fall 10 10
Headache 8 8
Convulsion/Seizure 8 8
Laceration(s) 6 6
Abscess 5 5
Cerebrospinal Fluid Leakage 4 4
Seizures 4 4
Post Traumatic Wound Infection 3 3
Cognitive Changes 3 3
Speech Disorder 3 3
Limb Fracture 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Vertebral Fracture 2 2
Electric Shock 2 2
Hip Fracture 2 2
Skin Erosion 2 2
Intracranial Hemorrhage 2 2
High Blood Pressure/ Hypertension 1 1
Hematoma 1 1
Memory Loss/Impairment 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Paresis 1 1
Dysphagia/ Odynophagia 1 1
Fatigue 1 1
Bone Fracture(s) 1 1
Erosion 1 1
Cellulitis 1 1
Abrasion 1 1
Tinnitus 1 1
Myalgia 1 1
Radiodermatitis 1 1
Seizures, Focal 1 1
Anxiety 1 1
Distress 1 1
Toxicity 1 1
Sensitivity of Teeth 1 1
Ambulation Difficulties 1 1
Hydrocephalus 1 1
Balance Problems 1 1
Osteomyelitis 1 1
Solid Tumour 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Multiple Fractures 1 1

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