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	826	826
Break	334	334
Fracture	297	297
Disconnection	291	291
Incorrect, Inadequate or Imprecise Result or Readings	272	272
Output Problem	149	149
Electrical /Electronic Property Problem	67	67
Incorrect Measurement	64	64
Infusion or Flow Problem	62	62
Insufficient Information	45	45
Display or Visual Feedback Problem	38	38
Complete Blockage	36	36
Failure to Read Input Signal	35	35
Device Dislodged or Dislocated	35	35
No Device Output	34	34
Leak/Splash	31	31
Loose or Intermittent Connection	31	31
Adverse Event Without Identified Device or Use Problem	31	31
Failure to Zero	31	31
Connection Problem	28	28
Low Readings	27	27
Device Sensing Problem	22	22
High Readings	22	22
Unable to Obtain Readings	15	15
Appropriate Term/Code Not Available	12	12
Signal Artifact/Noise	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
Loss of or Failure to Bond	9	9
Pressure Problem	8	8
Material Split, Cut or Torn	7	7
Mechanical Jam	7	7
Use of Device Problem	7	7
Unexpected Shutdown	6	6
Audible Prompt/Feedback Problem	6	6
Material Integrity Problem	6	6
Unstable	5	5
Crack	5	5
Detachment of Device or Device Component	4	4
Obstruction of Flow	4	4
Stretched	4	4
Communication or Transmission Problem	4	4
Material Fragmentation	4	4
Migration	3	3
Power Problem	3	3
Device Difficult to Program or Calibrate	3	3
Battery Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1751	1751
Insufficient Information	233	233
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
Device Embedded In Tissue or Plaque	8	8
Hematoma	8	8
Intracranial Hemorrhage	7	7
Not Applicable	4	4
Hydrocephalus	3	3
Coma	3	3
Vomiting	3	3
Hemorrhage/Bleeding	3	3
Malaise	3	3
Ambulation Difficulties	3	3
Death	3	3
Cerebral Edema	3	3
Unspecified Nervous System Problem	2	2
Muscle Weakness	2	2
Meningitis	2	2
Convulsion/Seizure	2	2
Visual Disturbances	2	2
No Code Available	2	2
Brain Injury	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
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
Post Operative Wound Infection	1	1