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
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
RAUMEDIC AG
	SUBSTANTIALLY EQUIVALENT	1
SOPHYSA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	907	907
Break	398	399
Fracture	360	361
Disconnection	312	312
Incorrect, Inadequate or Imprecise Result or Readings	310	310
Output Problem	154	154
Incorrect Measurement	103	103
Electrical /Electronic Property Problem	69	69
Infusion or Flow Problem	68	68
Unexpected Shutdown	61	61
Insufficient Device Problem Information	59	59
No Device Output	47	47
Device Dislodged or Dislocated	42	42
Complete Blockage	42	42
Display or Visual Feedback Problem	39	39
Device Sensing Problem	37	37
Failure to Read Input Signal	36	36
Adverse Event Without Identified Device or Use Problem	35	35
Failure to Zero	34	34
Loose or Intermittent Connection	34	34
Leak/Splash	32	32
Low Readings	27	27
Connection Problem	27	27
High Readings	25	25
Signal Artifact/Noise	17	17
Unable to Obtain Readings	14	14
Audible Prompt/Feedback Problem	13	13
Imprecise or Erratic Results	12	12
Mechanical Problem	11	11
Appropriate Device Problem Term/Code Not Available	11	11
Device-Device Incompatibility	10	10
Loss of or Failure to Bond	10	10
Mechanical Jam	9	9
Device Displays Incorrect Message	9	9
Image Display Error/Artifact	9	9
Use of Device Problem	8	8
Nonstandard Device	8	8
Material Split, Cut or Torn	8	8
Pressure Problem	8	8
Material Integrity Problem	6	6
Communication or Transmission Problem	5	5
Unstable	5	5
Stretched	4	4
Failure to Transmit Record	4	4
Crack	4	4
Improper or Incorrect Procedure or Method	4	4
Obstruction of Flow	4	4
Failure to Calibrate	4	4
Component Missing	4	4
Material Fragmentation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2045	2046
Insufficient Information	331	331
No Known Impact Or Consequence To Patient	165	165
Cerebrospinal Fluid Leakage	73	73
Injury	52	52
Unspecified Infection	40	40
Failure of Implant	39	39
No Consequences Or Impact To Patient	36	36
Unspecified Tissue Injury	21	21
Bacterial Infection	15	15
Foreign Body In Patient	12	12
Headache	12	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	12	12
Device Embedded In Tissue or Plaque	10	10
Fever	9	9
Hematoma	8	8
Intracranial Hemorrhage	7	7
Hemorrhage/Blood Loss/Bleeding	4	4
Cerebral Edema	4	4
Not Applicable	4	4
Intracranial Pressure Increased	4	4
Pneumocephalus	3	3
Malaise	3	3
Ambulation or Postural Difficulties	3	3
Coma	3	3
Vomiting	3	3
Brain Injury	3	3
Hydrocephalus	3	3
Death	3	3
Swelling/ Edema	2	2
No Patient Involvement	2	2
Visual Disturbances	2	2
Convulsion/Seizure	2	2
Unspecified Nervous System Problem	2	2
Muscle Weakness/Atrophy	2	2
Pain	2	2
Meningitis	2	2
No Code Available	2	2
Loss of consciousness	1	1
Seizures	1	1
Vessel Or Plaque, Device Embedded In	1	1
Abrasion	1	1
No Information	1	1
Cough	1	1
Cardiac Arrest	1	1
Visual Impairment	1	1
Idiopathic Intracranial Hypertension	1	1
Post Operative Wound Infection	1	1
Air Embolism	1	1
Confusion/ Disorientation	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