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TPLC
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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
BRANCHPOINT TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
CODMAN & SHURTLEFF, INC
SUBSTANTIALLY EQUIVALENT
1
CODMAN & SHURTLEFF, INC.
SUBSTANTIALLY EQUIVALENT
1
INNERSPACE NEURO SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES CORP.
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
SUBSTANTIALLY EQUIVALENT
2
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
3
RAUMEDIC AG
SUBSTANTIALLY EQUIVALENT
1
SOPHYSA, SA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
419
419
2017
439
439
2018
299
299
2019
260
260
2020
268
268
2021
211
211
2022
424
424
2023
746
746
2024
283
283
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
709
709
Incorrect, Inadequate or Imprecise Result or Readings
424
424
Break
354
354
Disconnection
316
316
Fracture
220
220
Output Problem
157
157
Device Operates Differently Than Expected
138
138
Device Displays Incorrect Message
93
93
Incorrect Measurement
93
93
Low Readings
92
92
Electrical /Electronic Property Problem
87
87
Unable to Obtain Readings
79
79
High Readings
78
78
Device Operational Issue
70
70
Leak/Splash
67
67
Adverse Event Without Identified Device or Use Problem
67
67
Use of Device Problem
63
63
Insufficient Information
57
57
Appropriate Term/Code Not Available
56
56
Failure to Zero
55
55
Infusion or Flow Problem
49
49
Connection Problem
46
46
Display or Visual Feedback Problem
46
46
Loose or Intermittent Connection
41
41
No Device Output
37
37
Failure to Read Input Signal
35
35
Device Sensing Problem
35
35
Device Dislodged or Dislocated
35
35
False Reading From Device Non-Compliance
29
29
Complete Blockage
26
26
Improper Device Output
21
21
Device Inoperable
17
17
No Display/Image
17
17
Pressure Problem
15
15
Device Difficult to Program or Calibrate
14
14
Failure to Power Up
14
14
Mechanical Problem
13
13
Detachment Of Device Component
13
13
Crack
13
13
Defective Device
13
13
Communication or Transmission Problem
13
13
Mechanical Jam
13
13
Material Integrity Problem
12
12
Device-Device Incompatibility
12
12
Defective Component
12
12
Bent
12
12
Erratic or Intermittent Display
12
12
Difficult to Insert
12
12
Occlusion Within Device
12
12
Failure to Sense
11
11
Improper or Incorrect Procedure or Method
11
11
Incorrect Or Inadequate Test Results
9
9
Erratic Results
9
9
Power Problem
8
8
Device Damaged Prior to Use
8
8
Battery Problem
8
8
Detachment of Device or Device Component
8
8
Loss of Power
8
8
Image Display Error/Artifact
8
8
Obstruction of Flow
7
7
Temperature Problem
7
7
Material Split, Cut or Torn
6
6
Failure to Calibrate
6
6
Product Quality Problem
6
6
Entrapment of Device
6
6
Material Fragmentation
6
6
Device Alarm System
6
6
Signal Artifact/Noise
5
5
Difficult to Remove
5
5
Decrease in Pressure
5
5
Failure to Select Signal
5
5
Overheating of Device
5
5
Device Or Device Fragments Location Unknown
5
5
Device Stops Intermittently
5
5
Malposition of Device
5
5
Calibration Problem
5
5
Activation, Positioning or Separation Problem
4
4
Invalid Sensing
4
4
High Test Results
4
4
Increase in Pressure
4
4
Component Incompatible
4
4
False Negative Result
4
4
Data Problem
4
4
Patient Data Problem
4
4
Device Handling Problem
4
4
Material Twisted/Bent
4
4
Positioning Problem
4
4
Protective Measures Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Noise, Audible
3
3
Migration
3
3
Material Discolored
3
3
Material Puncture/Hole
3
3
Failure to Reset
3
3
Device Difficult to Setup or Prepare
3
3
Device Issue
3
3
Failure to Advance
3
3
Component Missing
3
3
Self-Activation or Keying
3
3
Sticking
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1331
1331
No Known Impact Or Consequence To Patient
851
851
No Information
351
351
No Consequences Or Impact To Patient
302
302
Insufficient Information
152
152
Failure of Implant
75
75
Cerebrospinal Fluid Leakage
67
67
Injury
67
67
No Patient Involvement
63
63
Unspecified Infection
51
51
No Code Available
36
36
Device Embedded In Tissue or Plaque
25
25
Death
23
23
Unspecified Tissue Injury
21
21
Hematoma
19
19
Hemorrhage/Bleeding
17
17
Foreign Body In Patient
15
15
Headache
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Fever
11
11
Intracranial Hemorrhage
11
11
Patient Problem/Medical Problem
10
10
Complaint, Ill-Defined
9
9
Not Applicable
8
8
Bacterial Infection
8
8
Therapeutic Response, Decreased
7
7
Neurological Deficit/Dysfunction
7
7
Hydrocephalus
6
6
Coma
5
5
Brain Injury
4
4
Hernia
4
4
Ambulation Difficulties
4
4
Meningitis
3
3
Therapeutic Effects, Unexpected
3
3
Muscle Weakness
2
2
Ischemia
2
2
Test Result
2
2
Impaired Healing
2
2
Contusion
2
2
Tissue Damage
2
2
Hemorrhage, Cerebral
2
2
Convulsion/Seizure
2
2
Malaise
2
2
High Blood Pressure/ Hypertension
2
2
Perforation
2
2
Staphylococcus Aureus
2
2
Paralysis
2
2
Cardiac Arrest
2
2
Vomiting
2
2
Pain
2
2
Unspecified Nervous System Problem
2
2
Swelling/ Edema
2
2
Edema
2
2
Missing Value Reason
1
1
Hypoxia
1
1
Overdose
1
1
Headache, Lumbar Puncture
1
1
Necrosis
1
1
Intraocular Pressure Increased
1
1
Irritation
1
1
Low Oxygen Saturation
1
1
Fluid Discharge
1
1
Loss of consciousness
1
1
Fall
1
1
Low Blood Pressure/ Hypotension
1
1
Respiratory Failure
1
1
Hemorrhage, Subarachnoid
1
1
Paraplegia
1
1
Dizziness
1
1
Head Injury
1
1
Shaking/Tremors
1
1
Cognitive Changes
1
1
Fungal Infection
1
1
Numbness
1
1
Air Embolism
1
1
Neck Stiffness
1
1
Swelling
1
1
Pregnancy
1
1
Paresis
1
1
Death, Intrauterine Fetal
1
1
Intraocular Pressure, Delayed, Uncontrolled
1
1
Urinary Retention
1
1
Breast Neoplasm
1
1
Vascular System (Circulation), Impaired
1
1
Visual Impairment
1
1
Confusion/ Disorientation
1
1
Twitching
1
1
Alteration In Body Temperature
1
1
Weakness
1
1
Ventilator Dependent
1
1
Seizures
1
1
Post Operative Wound Infection
1
1
High Oxygen Saturation
1
1
Burning Sensation
1
1
Cough
1
1
Hemorrhage, Intraventricular
1
1
Fatigue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
I
Dec-14-2023
2
Integra LifeSciences Corp.
II
May-19-2023
3
Integra LifeSciences Corp.
I
Jul-22-2022
4
Integra LifeSciences Corp.
II
Oct-12-2019
5
Sophysa S.A.
II
May-15-2024
6
Spiegelberg Gmbh & Co. KG
II
Sep-26-2016
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