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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 1 2 4 4 3 3 1 3 2 1 4 1 1 2

MDR Year MDR Reports MDR Events
2014 11 11
2015 23 23
2016 9 9
2017 12 12
2018 23 23
2019 21 21
2020 30 30
2021 32 32
2022 26 26
2023 29 29
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 237 237
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 91 91
Post Operative Wound Infection 73 73
Fall 20 20
Ulcer 20 20
Laceration(s) 14 14
Seizures 12 12
Convulsion/Seizure 10 10
Death 9 9
Headache 8 8
Abscess 7 7
Cerebrospinal Fluid Leakage 6 6
Convulsion, Tonic 4 4
Limb Fracture 4 4
Electric Shock 4 4
Post Traumatic Wound Infection 4 4
Hip Fracture 3 3
Seizures, Focal 3 3
Cognitive Changes 3 3
Speech Disorder 3 3
Skin Erosion 3 3
Intracranial Hemorrhage 2 2
Infarction, Cerebral 2 2
Convulsion, Clonic 2 2
Pulmonary Embolism 2 2
Fatigue 2 2
Bone Fracture(s) 2 2
Respiratory Failure 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Vertebral Fracture 2 2
Osteomyelitis 1 1
Solid Tumour 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Shaking/Tremors 1 1
Ambulation Difficulties 1 1
Sensitivity of Teeth 1 1
Choking 1 1
Dry Mouth 1 1
Multiple Fractures 1 1
No Code Available 1 1
Hydrocephalus 1 1
Balance Problems 1 1
Hematoma 1 1
Memory Loss/Impairment 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Paresis 1 1
Abrasion 1 1
Erosion 1 1
Cellulitis 1 1
Contusion 1 1
Dysphagia/ Odynophagia 1 1
Myalgia 1 1
Radiodermatitis 1 1
Anxiety 1 1
Distress 1 1
Toxicity 1 1
High Blood Pressure/ Hypertension 1 1
Seizures, Focal Motor 1 1
Skull Fracture 1 1
Strangulation 1 1
Thrombosis 1 1
Tinnitus 1 1
Seizures, Grand-Mal 1 1
Twitching 1 1

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