TPLC - Total Product Life Cycle

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Device	device, monitoring, intracranial pressure
Regulation Description	Intracranial pressure monitoring device.
Product Code	GWM
Regulation Number	882.1620
Device Class	2

Premarket Reviews
Manufacturer	Decision
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.
	SUBSTANTIALLY EQUIVALENT	1
BRAINCARE DESENVOLVIMENTO E INOVAÇÃO TECNOLÓGICA S.A.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
RAUMEDIC AG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	875	875
Break	373	374
Fracture	332	333
Disconnection	294	294
Incorrect, Inadequate or Imprecise Result or Readings	257	257
Output Problem	136	136
Incorrect Measurement	88	88
Infusion or Flow Problem	65	65
Unexpected Shutdown	57	57
Insufficient Information	48	48
No Device Output	36	36
Complete Blockage	36	36
Failure to Read Input Signal	35	35
Display or Visual Feedback Problem	33	33
Device Dislodged or Dislocated	32	32
Loose or Intermittent Connection	31	31
Failure to Zero	31	31
Adverse Event Without Identified Device or Use Problem	29	29
Leak/Splash	27	27
Connection Problem	27	27
Device Sensing Problem	26	26
Low Readings	25	25
High Readings	21	21
Electrical /Electronic Property Problem	15	15
Audible Prompt/Feedback Problem	13	13
Unable to Obtain Readings	13	13
Erratic Results	12	12
Signal Artifact/Noise	12	12
Loss of or Failure to Bond	9	9
Mechanical Jam	9	9
Appropriate Term/Code Not Available	9	9
Image Display Error/Artifact	9	9
Pressure Problem	7	7
Material Split, Cut or Torn	7	7
Unstable	5	5
Material Integrity Problem	5	5
Crack	5	5
Mechanical Problem	5	5
Improper or Incorrect Procedure or Method	4	4
Failure to Transmit Record	4	4
Device-Device Incompatibility	4	4
Stretched	4	4
Component Missing	4	4
Detachment of Device or Device Component	4	4
Deformation Due to Compressive Stress	3	3
Device Displays Incorrect Message	3	3
Failure to Sense	3	3
Overheating of Device	3	3
Failure to Calibrate	3	3
Material Fragmentation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1918	1919
Insufficient Information	310	310
Cerebrospinal Fluid Leakage	69	69
Failure of Implant	37	37
Unspecified Infection	36	36
Unspecified Tissue Injury	21	21
Bacterial Infection	14	14
No Known Impact Or Consequence To Patient	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Headache	11	11
Foreign Body In Patient	10	10
Device Embedded In Tissue or Plaque	9	9
Fever	9	9
Hematoma	7	7
Intracranial Hemorrhage	7	7
Injury	7	7
Cerebral Edema	4	4
Hemorrhage/Bleeding	4	4
Malaise	3	3
Vomiting	3	3
Hydrocephalus	3	3
Brain Injury	3	3
No Consequences Or Impact To Patient	3	3
Ambulation Difficulties	3	3
Unspecified Nervous System Problem	2	2
Muscle Weakness	2	2
Visual Disturbances	2	2
Coma	2	2
Swelling/ Edema	2	2
Convulsion/Seizure	2	2
Meningitis	2	2
Cognitive Changes	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Confusion/ Disorientation	1	1
Perforation	1	1
Skin Inflammation/ Irritation	1	1
Dizziness	1	1
Burning Sensation	1	1
Nausea	1	1
Hernia	1	1
Exposure to Body Fluids	1	1
Discomfort	1	1
Visual Impairment	1	1
Pain	1	1
Abscess	1	1
Cough	1	1
Seizures	1	1
High Oxygen Saturation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra LifeSciences Corp.	I	Dec-14-2023
2	Integra LifeSciences Corp.	II	May-19-2023
3	Integra LifeSciences Corp.	I	Jul-22-2022
4	Integra LifeSciences Corp. (NeuroSciences)	II	Jan-08-2026
5	Medtronic Neurosurgery	I	Dec-19-2024
6	Smiths Medical ASD, Inc.	II	Oct-23-2024
7	Sophysa	II	Jan-08-2026
8	Sophysa S.A.	II	May-15-2024