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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	867	867
Break	370	370
Fracture	328	328
Disconnection	297	297
Incorrect, Inadequate or Imprecise Result or Readings	283	283
Output Problem	152	152
Incorrect Measurement	85	85
Electrical /Electronic Property Problem	68	68
Infusion or Flow Problem	64	64
Insufficient Information	55	55
No Device Output	39	39
Unexpected Shutdown	39	39
Display or Visual Feedback Problem	38	38
Complete Blockage	38	38
Device Dislodged or Dislocated	36	36
Failure to Read Input Signal	35	35
Adverse Event Without Identified Device or Use Problem	32	32
Leak/Splash	31	31
Failure to Zero	31	31
Loose or Intermittent Connection	30	30
Connection Problem	28	28
Low Readings	27	27
Device Sensing Problem	25	25
High Readings	22	22
Unable to Obtain Readings	15	15
Audible Prompt/Feedback Problem	13	13
Appropriate Term/Code Not Available	12	12
Erratic Results	12	12
Signal Artifact/Noise	12	12
Device Displays Incorrect Message	11	11
Mechanical Problem	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
Pressure Problem	8	8
Use of Device Problem	8	8
Material Split, Cut or Torn	7	7
Material Integrity Problem	6	6
Crack	6	6
Unstable	5	5
Detachment of Device or Device Component	5	5
Communication or Transmission Problem	5	5
Failure to Transmit Record	4	4
Improper or Incorrect Procedure or Method	4	4
Material Fragmentation	4	4
Stretched	4	4
Obstruction of Flow	4	4
Failure to Sense	3	3
Defective Component	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1875	1875
Insufficient Information	276	276
No Known Impact Or Consequence To Patient	165	165
Cerebrospinal Fluid Leakage	70	70
Injury	52	52
Failure of Implant	39	39
Unspecified Infection	38	38
No Consequences Or Impact To Patient	36	36
Unspecified Tissue Injury	21	21
Bacterial Infection	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Headache	12	12
Foreign Body In Patient	10	10
Device Embedded In Tissue or Plaque	9	9
Fever	9	9
Hematoma	8	8
Intracranial Hemorrhage	7	7
Cerebral Edema	4	4
Not Applicable	4	4
Hydrocephalus	3	3
Coma	3	3
Vomiting	3	3
Hemorrhage/Bleeding	3	3
Malaise	3	3
Brain Injury	3	3
Ambulation Difficulties	3	3
Death	3	3
Unspecified Nervous System Problem	2	2
Muscle Weakness	2	2
Convulsion/Seizure	2	2
Meningitis	2	2
Visual Disturbances	2	2
No Code Available	2	2
No Patient Involvement	2	2
Swelling/ Edema	2	2
Hemorrhage, Subarachnoid	1	1
Loss of consciousness	1	1
Irritability	1	1
Respiratory Failure	1	1
Cough	1	1
Missing Value Reason	1	1
Abscess	1	1
Death, Intrauterine Fetal	1	1
Visual Impairment	1	1
Pain	1	1
Hernia	1	1
Urinary Retention	1	1
Exposure to Body Fluids	1	1
Burning Sensation	1	1
Confusion/ Disorientation	1	1