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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	841	841
Incorrect, Inadequate or Imprecise Result or Readings	386	386
Break	357	357
Fracture	305	305
Disconnection	295	295
Output Problem	161	161
Electrical /Electronic Property Problem	70	70
Incorrect Measurement	69	69
Infusion or Flow Problem	62	62
Insufficient Information	53	53
Display or Visual Feedback Problem	43	43
Adverse Event Without Identified Device or Use Problem	39	39
Device Dislodged or Dislocated	37	37
Complete Blockage	36	36
No Device Output	36	36
Failure to Read Input Signal	35	35
Leak/Splash	34	34
Loose or Intermittent Connection	33	33
Failure to Zero	32	32
Low Readings	28	28
Connection Problem	28	28
Device Sensing Problem	27	27
Unable to Obtain Readings	25	25
High Readings	22	22
Appropriate Term/Code Not Available	18	18
Use of Device Problem	16	16
Signal Artifact/Noise	12	12
Erratic Results	11	11
Device Displays Incorrect Message	11	11
Mechanical Problem	11	11
Device Difficult to Program or Calibrate	11	11
Device-Device Incompatibility	10	10
Loss of or Failure to Bond	9	9
Image Display Error/Artifact	9	9
Pressure Problem	8	8
Communication or Transmission Problem	7	7
Material Integrity Problem	7	7
Mechanical Jam	7	7
Material Split, Cut or Torn	7	7
Detachment of Device or Device Component	6	6
Defective Device	6	6
Crack	6	6
Unexpected Shutdown	6	6
Audible Prompt/Feedback Problem	6	6
Obstruction of Flow	5	5
Unstable	5	5
Material Fragmentation	4	4
Stretched	4	4
Device Damaged Prior to Use	4	4
Power Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1751	1751
No Known Impact Or Consequence To Patient	259	259
Insufficient Information	233	233
No Consequences Or Impact To Patient	124	124
Cerebrospinal Fluid Leakage	73	73
Injury	63	63
Failure of Implant	61	61
Unspecified Infection	36	36
Unspecified Tissue Injury	21	21
Bacterial Infection	17	17
Hematoma	13	13
Headache	12	12
No Information	12	12
Device Embedded In Tissue or Plaque	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Death	10	10
Fever	10	10
Foreign Body In Patient	10	10
Intracranial Hemorrhage	8	8
Patient Problem/Medical Problem	6	6
Ambulation Difficulties	4	4
Hemorrhage/Bleeding	4	4
No Patient Involvement	4	4
Not Applicable	4	4
Coma	3	3
Meningitis	3	3
Malaise	3	3
Brain Injury	3	3
Vomiting	3	3
Therapeutic Effects, Unexpected	3	3
Hydrocephalus	3	3
Cerebral Edema	3	3
Visual Disturbances	2	2
No Code Available	2	2
Convulsion/Seizure	2	2
Muscle Weakness	2	2
Unspecified Nervous System Problem	2	2
Impaired Healing	2	2
Edema	2	2
Contusion	2	2
Swelling/ Edema	2	2
Missing Value Reason	1	1
Fluid Discharge	1	1
Vascular System (Circulation), Impaired	1	1
Cough	1	1
Confusion/ Disorientation	1	1
Cognitive Changes	1	1
Respiratory Failure	1	1
High Oxygen Saturation	1	1
Post Operative Wound Infection	1	1