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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)
2019 2020 2021 2022 2023 2024
2 1 4 1 1 2

MDR Year MDR Reports MDR Events
2019 21 21
2020 30 30
2021 32 32
2022 26 26
2023 29 29
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 152 152
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 69 69
Post Operative Wound Infection 53 53
Ulcer 17 17
Fall 13 13
Laceration(s) 11 11
Convulsion/Seizure 10 10
Abscess 5 5
Cerebrospinal Fluid Leakage 4 4
Headache 3 3
Speech Disorder 3 3
Limb Fracture 3 3
Post Traumatic Wound Infection 3 3
Electric Shock 3 3
Seizures 2 2
Skin Erosion 2 2
Intracranial Hemorrhage 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Vertebral Fracture 2 2
Cognitive Changes 2 2
Osteomyelitis 1 1
Solid Tumour 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
High Blood Pressure/ Hypertension 1 1
Hematoma 1 1
Memory Loss/Impairment 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
Strangulation 1 1
Tinnitus 1 1
Myalgia 1 1
Radiodermatitis 1 1
Anxiety 1 1
Distress 1 1
Hip Fracture 1 1
Sensitivity of Teeth 1 1
Hydrocephalus 1 1
Balance Problems 1 1
Ambulation Difficulties 1 1
Multiple Fractures 1 1

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