TPLC - Total Product Life Cycle

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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
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	779	779
Incorrect, Inadequate or Imprecise Result or Readings	351	351
Break	297	297
Disconnection	284	284
Fracture	249	249
Output Problem	159	159
Electrical /Electronic Property Problem	70	70
Incorrect Measurement	59	59
Infusion or Flow Problem	57	57
Insufficient Information	51	51
No Device Output	36	36
Adverse Event Without Identified Device or Use Problem	36	36
Failure to Read Input Signal	35	35
Device Dislodged or Dislocated	35	35
Display or Visual Feedback Problem	33	33
Complete Blockage	33	33
Leak/Splash	32	32
Loose or Intermittent Connection	30	30
Low Readings	28	28
Failure to Zero	27	27
Connection Problem	26	26
Unable to Obtain Readings	24	24
Device Sensing Problem	23	23
High Readings	21	21
Appropriate Term/Code Not Available	18	18
Use of Device Problem	16	16
Device Displays Incorrect Message	11	11
Device Difficult to Program or Calibrate	11	11
Erratic Results	11	11
Device-Device Incompatibility	10	10
Mechanical Problem	10	10
Pressure Problem	8	8
Image Display Error/Artifact	8	8
Mechanical Jam	7	7
Communication or Transmission Problem	7	7
Material Integrity Problem	7	7
Detachment of Device or Device Component	6	6
Defective Device	6	6
Crack	6	6
Material Split, Cut or Torn	6	6
Obstruction of Flow	5	5
Device Damaged Prior to Use	4	4
Audible Prompt/Feedback Problem	4	4
Signal Artifact/Noise	4	4
Material Fragmentation	4	4
Loss of or Failure to Bond	4	4
Power Problem	3	3
Migration	3	3
Overheating of Device	3	3
Deformation Due to Compressive Stress	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1549	1549
No Known Impact Or Consequence To Patient	259	259
Insufficient Information	196	196
No Consequences Or Impact To Patient	124	124
Cerebrospinal Fluid Leakage	69	69
Injury	63	63
Failure of Implant	61	61
Unspecified Infection	35	35
Unspecified Tissue Injury	21	21
Bacterial Infection	16	16
Hematoma	13	13
No Information	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Headache	11	11
Device Embedded In Tissue or Plaque	10	10
Death	10	10
Foreign Body In Patient	10	10
Fever	10	10
Intracranial Hemorrhage	8	8
Patient Problem/Medical Problem	6	6
Ambulation Difficulties	4	4
Hemorrhage/Bleeding	4	4
Not Applicable	4	4
No Patient Involvement	4	4
Therapeutic Effects, Unexpected	3	3
Hydrocephalus	3	3
Coma	3	3
Malaise	3	3
Brain Injury	3	3
Impaired Healing	2	2
Unspecified Nervous System Problem	2	2
Contusion	2	2
Visual Disturbances	2	2
Edema	2	2
Meningitis	2	2
Vomiting	2	2
No Code Available	2	2
Convulsion/Seizure	2	2
Muscle Weakness	2	2
Swelling/ Edema	2	2
Death, Intrauterine Fetal	1	1
Vessel Or Plaque, Device Embedded In	1	1
Respiratory Failure	1	1
Ventilator Dependent	1	1
Loss of consciousness	1	1
Hemorrhage, Subarachnoid	1	1
Air Embolism	1	1
Complaint, Ill-Defined	1	1
High Oxygen Saturation	1	1
Fatigue	1	1