TPLC - Total Product Life Cycle

show TPLC since

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 Code	NZK
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
4	1	1	7	4	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	497	497
Device-Device Incompatibility	1	1
Insufficient Information	1	1
Use of Device Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	111	111
Wound Dehiscence	86	86
Laceration(s)	72	72
Post Operative Wound Infection	67	67
Skin Infection	32	32
Ulcer	30	30
Fall	29	29
Headache	18	18
Hypersensitivity/Allergic reaction	17	17
Convulsion/Seizure	15	15
Impaired Healing	9	9
Post Traumatic Wound Infection	9	9
Cellulitis	9	9
Abscess	8	8
Arthralgia	7	7
Electric Shock	6	6
Limb Fracture	6	6
Distress	5	5
Strangulation	5	5
Cerebral Edema	4	4
Cerebrospinal Fluid Leakage	4	4
Swelling/ Edema	4	4
Anxiety	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Speech Disorder	4	4
Hematoma	3	3
Vertebral Fracture	3	3
Osteomyelitis	3	3
Depression	3	3
Balance Problems	3	3
Muscle/Tendon Damage	3	3
Multiple Fractures	2	2
Abrasion	2	2
Myalgia	2	2
Blister	2	2
Localized Skin Lesion	2	2
Head Injury	2	2
Confusion/ Disorientation	2	2
Burn(s)	2	2
Intracranial Hemorrhage	2	2
Bruise/Contusion	2	2
Neck Pain	2	2
Bone Fracture(s)	2	2
Pain	2	2
Solid Tumour	2	2
High Blood Pressure/ Hypertension	1	1
Ambulation Difficulties	1	1
Sleep Dysfunction	1	1
Ischemia Stroke	1	1
Neuralgia	1	1