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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	805	805
Break	304	304
Disconnection	291	291
Fracture	268	268
Incorrect, Inadequate or Imprecise Result or Readings	261	261
Output Problem	149	149
Electrical /Electronic Property Problem	67	67
Incorrect Measurement	62	62
Infusion or Flow Problem	60	60
Insufficient Information	44	44
Display or Visual Feedback Problem	38	38
Failure to Read Input Signal	35	35
Complete Blockage	35	35
No Device Output	34	34
Device Dislodged or Dislocated	34	34
Loose or Intermittent Connection	31	31
Leak/Splash	30	30
Adverse Event Without Identified Device or Use Problem	30	30
Failure to Zero	29	29
Connection Problem	28	28
Low Readings	27	27
High Readings	22	22
Device Sensing Problem	21	21
Unable to Obtain Readings	15	15
Appropriate Term/Code Not Available	12	12
Erratic Results	11	11
Device Displays Incorrect Message	11	11
Mechanical Problem	10	10
Device-Device Incompatibility	10	10
Image Display Error/Artifact	9	9
Pressure Problem	8	8
Loss of or Failure to Bond	8	8
Signal Artifact/Noise	8	8
Mechanical Jam	7	7
Use of Device Problem	7	7
Material Split, Cut or Torn	6	6
Material Integrity Problem	6	6
Crack	5	5
Audible Prompt/Feedback Problem	5	5
Unstable	5	5
Communication or Transmission Problem	4	4
Detachment of Device or Device Component	4	4
Unexpected Shutdown	4	4
Obstruction of Flow	4	4
Material Fragmentation	4	4
Power Problem	3	3
Migration	3	3
Device Difficult to Program or Calibrate	3	3
Deformation Due to Compressive Stress	3	3
Battery Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1685	1685
Insufficient Information	224	224
No Known Impact Or Consequence To Patient	165	165
Cerebrospinal Fluid Leakage	69	69
Injury	52	52
Failure of Implant	39	39
No Consequences Or Impact To Patient	36	36
Unspecified Infection	30	30
Unspecified Tissue Injury	21	21
Bacterial Infection	15	15
Headache	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Foreign Body In Patient	9	9
Fever	9	9
Hematoma	8	8
Intracranial Hemorrhage	7	7
Device Embedded In Tissue or Plaque	6	6
Not Applicable	4	4
Cerebral Edema	3	3
Ambulation Difficulties	3	3
Death	3	3
Hemorrhage/Bleeding	3	3
Hydrocephalus	3	3
Malaise	3	3
Coma	3	3
Vomiting	3	3
Convulsion/Seizure	2	2
Swelling/ Edema	2	2
No Patient Involvement	2	2
Visual Disturbances	2	2
Unspecified Nervous System Problem	2	2
Muscle Weakness	2	2
No Code Available	2	2
Brain Injury	2	2
Confusion/ Disorientation	1	1
Post Operative Wound Infection	1	1
Burning Sensation	1	1
Cardiac Arrest	1	1
Cognitive Changes	1	1
Exposure to Body Fluids	1	1
Urinary Retention	1	1
Hernia	1	1
Perforation	1	1
Pain	1	1
Visual Impairment	1	1
Missing Value Reason	1	1
No Information	1	1
Dizziness	1	1
Cough	1	1
Seizures	1	1