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
SOPHYSA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	885	885
Break	386	387
Fracture	343	344
Disconnection	303	303
Incorrect, Inadequate or Imprecise Result or Readings	272	272
Output Problem	139	139
Incorrect Measurement	95	95
Infusion or Flow Problem	68	68
Unexpected Shutdown	61	61
Insufficient Information	49	49
No Device Output	42	42
Complete Blockage	38	38
Failure to Read Input Signal	36	36
Display or Visual Feedback Problem	36	36
Device Dislodged or Dislocated	36	36
Device Sensing Problem	36	36
Loose or Intermittent Connection	35	35
Failure to Zero	34	34
Adverse Event Without Identified Device or Use Problem	30	30
Leak/Splash	27	27
Connection Problem	27	27
Low Readings	25	25
High Readings	21	21
Signal Artifact/Noise	17	17
Electrical /Electronic Property Problem	16	16
Unable to Obtain Readings	13	13
Audible Prompt/Feedback Problem	13	13
Erratic Results	12	12
Loss of or Failure to Bond	10	10
Mechanical Jam	9	9
Image Display Error/Artifact	9	9
Appropriate Term/Code Not Available	9	9
Material Split, Cut or Torn	8	8
Nonstandard Device	8	8
Pressure Problem	7	7
Material Integrity Problem	5	5
Crack	5	5
Improper or Incorrect Procedure or Method	5	5
Mechanical Problem	5	5
Unstable	5	5
Failure to Transmit Record	4	4
Detachment of Device or Device Component	4	4
Device-Device Incompatibility	4	4
Component Missing	4	4
Stretched	4	4
Migration	3	3
Failure to Calibrate	3	3
Overheating of Device	3	3
Device Displays Incorrect Message	3	3
Deformation Due to Compressive Stress	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2002	2003
Insufficient Information	326	326
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	11	11
Device Embedded In Tissue or Plaque	9	9
Fever	9	9
Injury	7	7
Hematoma	7	7
Intracranial Hemorrhage	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
Abrasion	1	1
Cognitive Changes	1	1
Perforation	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Confusion/ Disorientation	1	1
Skin Inflammation/ Irritation	1	1
Dizziness	1	1
Burning Sensation	1	1
Seizures	1	1
Exposure to Body Fluids	1	1
Hernia	1	1
Discomfort	1	1
Pain	1	1
Visual Impairment	1	1
Abscess	1	1
Nausea	1	1
Cough	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