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	2
BRAINCARE DESENVOLVIMENTO E INOVAÇÃO TECNOLÓGICA S.A.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES CORP.
	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	917	917
Incorrect, Inadequate or Imprecise Result or Readings	424	424
Break	421	422
Fracture	361	362
Disconnection	309	309
Output Problem	168	168
Incorrect Measurement	104	104
Electrical /Electronic Property Problem	72	72
Infusion or Flow Problem	66	66
Insufficient Information	66	66
Unexpected Shutdown	59	59
Display or Visual Feedback Problem	46	46
No Device Output	44	44
Adverse Event Without Identified Device or Use Problem	42	42
Device Dislodged or Dislocated	41	41
Device Sensing Problem	39	39
Complete Blockage	39	39
Leak/Splash	36	36
Failure to Read Input Signal	36	36
Loose or Intermittent Connection	34	34
Failure to Zero	32	32
Connection Problem	28	28
Low Readings	28	28
Unable to Obtain Readings	25	25
High Readings	23	23
Appropriate Term/Code Not Available	18	18
Use of Device Problem	17	17
Signal Artifact/Noise	14	14
Audible Prompt/Feedback Problem	13	13
Erratic Results	12	12
Mechanical Problem	12	12
Device Difficult to Program or Calibrate	11	11
Device Displays Incorrect Message	11	11
Device-Device Incompatibility	10	10
Loss of or Failure to Bond	9	9
Mechanical Jam	9	9
Image Display Error/Artifact	9	9
Material Split, Cut or Torn	8	8
Communication or Transmission Problem	8	8
Pressure Problem	8	8
Detachment of Device or Device Component	7	7
Crack	7	7
Material Integrity Problem	7	7
Defective Device	6	6
Unstable	5	5
Improper or Incorrect Procedure or Method	5	5
Obstruction of Flow	5	5
Component Missing	4	4
Stretched	4	4
Difficult to Insert	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1986	1987
Insufficient Information	322	322
No Known Impact Or Consequence To Patient	259	259
No Consequences Or Impact To Patient	124	124
Cerebrospinal Fluid Leakage	77	77
Injury	63	63
Failure of Implant	61	61
Unspecified Infection	46	46
Unspecified Tissue Injury	21	21
Bacterial Infection	17	17
Device Embedded In Tissue or Plaque	13	13
Foreign Body In Patient	13	13
Hematoma	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Headache	12	12
No Information	12	12
Death	10	10
Fever	10	10
Intracranial Hemorrhage	8	8
Patient Problem/Medical Problem	6	6
Hemorrhage/Bleeding	5	5
Cerebral Edema	4	4
Ambulation Difficulties	4	4
No Patient Involvement	4	4
Brain Injury	4	4
Not Applicable	4	4
Malaise	3	3
Meningitis	3	3
Therapeutic Effects, Unexpected	3	3
Vomiting	3	3
Coma	3	3
Hydrocephalus	3	3
Edema	2	2
Impaired Healing	2	2
Contusion	2	2
Unspecified Nervous System Problem	2	2
Muscle Weakness	2	2
Visual Disturbances	2	2
No Code Available	2	2
Convulsion/Seizure	2	2
Swelling/ Edema	2	2
Pain	2	2
Death, Intrauterine Fetal	1	1
Air Embolism	1	1
Vessel Or Plaque, Device Embedded In	1	1
Respiratory Failure	1	1
Ventilator Dependent	1	1
Irritability	1	1
Loss of consciousness	1	1
Complaint, Ill-Defined	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.	II	Oct-12-2019
5	Integra LifeSciences Corp. (NeuroSciences)	II	Jan-08-2026
6	Medtronic Neurosurgery	I	Dec-19-2024
7	Smiths Medical ASD, Inc.	II	Oct-23-2024
8	Sophysa	II	Jan-08-2026
9	Sophysa S.A.	II	May-15-2024