TPLC - Total Product Life Cycle

show TPLC since

Device	device, monitoring, intracranial pressure
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
BRANCHPOINT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CMA MICRODIALYSIS AB
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
DPCOM AS
	SUBSTANTIALLY EQUIVALENT	1
HEMEDEX INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
INNERSPACE NEURO SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INNERSPACE, INC
	SUBSTANTIALLY EQUIVALENT	1
INNERSPACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCE CORPORTATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES CORP.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
INTRGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
RAUMEDIC AG
	SUBSTANTIALLY EQUIVALENT	5
SOPHYSA, SA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	775	775
Break	494	494
Incorrect, Inadequate or Imprecise Result or Readings	466	466
Disconnection	391	391
Device Operates Differently Than Expected	254	254
Fracture	252	252
Device Displays Incorrect Message	192	192
Output Problem	168	168
Appropriate Term/Code Not Available	120	120
Leak/Splash	111	111
Unable to Obtain Readings	107	107
Low Readings	107	107
Incorrect Measurement	106	106
High Readings	99	99
Adverse Event Without Identified Device or Use Problem	91	91
Electrical /Electronic Property Problem	88	88
Use of Device Problem	78	78
Connection Problem	77	77
Device Operational Issue	70	70
Failure to Zero	70	70
Insufficient Information	70	70
Display or Visual Feedback Problem	66	66
Loose or Intermittent Connection	59	59
False Reading From Device Non-Compliance	57	57
Device Sensing Problem	56	56
Infusion or Flow Problem	54	54
No Display/Image	52	52
No Device Output	49	49
Device Inoperable	43	43
Device Dislodged or Dislocated	41	41
Failure to Read Input Signal	39	39
Defective Device	35	35
Complete Blockage	32	32
Improper Device Output	29	29
Signal Artifact/Noise	28	28
Failure to Power Up	28	28
Crack	27	27
Pressure Problem	27	27
Communication or Transmission Problem	26	26
Bent	23	23
Failure to Sense	22	22
Image Display Error/Artifact	20	20
Device Handling Problem	19	19
Defective Component	17	17
Occlusion Within Device	17	17
Difficult to Insert	17	17
Detachment Of Device Component	17	17
Battery Problem	17	17
Mechanical Problem	17	17
Mechanical Jam	16	16

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1482	1482
No Known Impact Or Consequence To Patient	1219	1219
No Information	499	499
No Consequences Or Impact To Patient	447	447
Insufficient Information	181	181
No Patient Involvement	172	172
No Code Available	119	119
Cerebrospinal Fluid Leakage	79	79
Failure of Implant	75	75
Injury	71	71
Unspecified Infection	57	57
Death	43	43
Device Embedded In Tissue or Plaque	30	30
Hematoma	23	23
Hemorrhage/Bleeding	21	21
Unspecified Tissue Injury	21	21
Complaint, Ill-Defined	18	18
Bacterial Infection	18	18
Foreign Body In Patient	15	15
Headache	15	15
Intracranial Hemorrhage	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Fever	12	12
Patient Problem/Medical Problem	10	10
Therapeutic Response, Decreased	10	10
Not Applicable	8	8
Neurological Deficit/Dysfunction	8	8
Brain Injury	6	6
Coma	6	6
Hydrocephalus	6	6
Vomiting	5	5
Hernia	4	4
Pain	4	4
Head Injury	4	4
Ambulation Difficulties	4	4
High Blood Pressure/ Hypertension	4	4
Edema	3	3
Malaise	3	3
Hemorrhage, Cerebral	3	3
Test Result	3	3
Hemorrhage, Subarachnoid	3	3
Therapeutic Effects, Unexpected	3	3
Meningitis	3	3
Swelling/ Edema	2	2
Aneurysm	2	2
Tissue Damage	2	2
Fall	2	2
Convulsion/Seizure	2	2
Pulmonary Embolism	2	2
Paralysis	2	2