TPLC - Total Product Life Cycle

show TPLC since

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	789	789
Incorrect, Inadequate or Imprecise Result or Readings	364	364
Break	303	303
Disconnection	287	287
Fracture	255	255
Output Problem	159	159
Electrical /Electronic Property Problem	70	70
Incorrect Measurement	59	59
Infusion or Flow Problem	57	57
Insufficient Information	51	51
Adverse Event Without Identified Device or Use Problem	37	37
No Device Output	36	36
Failure to Read Input Signal	35	35
Device Dislodged or Dislocated	35	35
Display or Visual Feedback Problem	35	35
Complete Blockage	34	34
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	22	22
Appropriate Term/Code Not Available	18	18
Use of Device Problem	16	16
Erratic Results	11	11
Device Difficult to Program or Calibrate	11	11
Device Displays Incorrect Message	11	11
Mechanical Problem	10	10
Device-Device Incompatibility	10	10
Image Display Error/Artifact	8	8
Pressure Problem	8	8
Communication or Transmission Problem	7	7
Mechanical Jam	7	7
Material Integrity Problem	7	7
Crack	6	6
Material Split, Cut or Torn	6	6
Detachment of Device or Device Component	6	6
Defective Device	6	6
Audible Prompt/Feedback Problem	5	5
Loss of or Failure to Bond	5	5
Obstruction of Flow	5	5
Material Fragmentation	4	4
Device Damaged Prior to Use	4	4
Unstable	4	4
Signal Artifact/Noise	4	4
Defective Component	3	3
Failure to Sense	3	3
Therapeutic or Diagnostic Output Failure	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1584	1584
No Known Impact Or Consequence To Patient	259	259
Insufficient Information	200	200
No Consequences Or Impact To Patient	124	124
Cerebrospinal Fluid Leakage	69	69
Injury	63	63
Failure of Implant	61	61
Unspecified Infection	36	36
Unspecified Tissue Injury	21	21
Bacterial Infection	17	17
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