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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
INTEGRA LIFESCIENCES CORP.
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2018
295
295
2019
260
260
2020
268
268
2021
211
211
2022
425
425
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
352
352
Fluid/Blood Leak
154
154
Break
144
144
Output Problem
114
114
Fracture
91
91
Electrical /Electronic Property Problem
60
60
Incorrect Measurement
51
51
Unable to Obtain Readings
46
46
Adverse Event Without Identified Device or Use Problem
37
37
Disconnection
34
34
Insufficient Information
33
33
Appropriate Term/Code Not Available
30
30
Infusion or Flow Problem
28
28
Low Readings
27
27
Failure to Zero
25
25
Connection Problem
25
25
High Readings
21
21
No Device Output
20
20
Leak/Splash
18
18
Use of Device Problem
17
17
Device Dislodged or Dislocated
16
16
Display or Visual Feedback Problem
16
16
Loose or Intermittent Connection
16
16
Failure to Read Input Signal
16
16
Device Sensing Problem
14
14
False Reading From Device Non-Compliance
11
11
Device Displays Incorrect Message
11
11
Device Difficult to Program or Calibrate
10
10
Complete Blockage
10
10
Device Operational Issue
9
9
Detachment of Device or Device Component
8
8
Mechanical Problem
8
8
Crack
7
7
Defective Device
7
7
Communication or Transmission Problem
7
7
Device-Device Incompatibility
7
7
Material Integrity Problem
7
7
Pressure Problem
6
6
Image Display Error/Artifact
6
6
Device Operates Differently Than Expected
6
6
Material Split, Cut or Torn
5
5
No Display/Image
4
4
Device Damaged Prior to Use
4
4
Difficult to Remove
4
4
False Negative Result
4
4
Power Problem
4
4
Defective Component
3
3
Material Fragmentation
3
3
Failure to Sense
3
3
Invalid Sensing
3
3
Increase in Pressure
3
3
Entrapment of Device
3
3
Overheating of Device
3
3
Obstruction of Flow
3
3
Therapeutic or Diagnostic Output Failure
3
3
Deformation Due to Compressive Stress
3
3
Calibration Problem
3
3
Activation, Positioning or Separation Problem
3
3
Erratic Results
2
2
Shipping Damage or Problem
2
2
Device Difficult to Setup or Prepare
2
2
Difficult to Insert
2
2
Device Alarm System
2
2
Failure to Reset
2
2
Malposition of Device
2
2
Audible Prompt/Feedback Problem
2
2
Device Issue
2
2
Failure to Power Up
2
2
Patient-Device Incompatibility
2
2
Material Twisted/Bent
2
2
Mechanical Jam
2
2
Protective Measures Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Improper Device Output
2
2
Device Stops Intermittently
2
2
Contamination
2
2
Battery Problem
2
2
Migration
2
2
Excessive Heating
1
1
Detachment Of Device Component
1
1
Peeled/Delaminated
1
1
Device Inoperable
1
1
Unstable
1
1
Compatibility Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Deformation
1
1
Low Test Results
1
1
Device Handling Problem
1
1
Installation-Related Problem
1
1
Material Protrusion/Extrusion
1
1
Sparking
1
1
Material Separation
1
1
Migration or Expulsion of Device
1
1
Loss of Power
1
1
Component Incompatible
1
1
Non Reproducible Results
1
1
Premature Separation
1
1
Device Markings/Labelling Problem
1
1
Difficult to Advance
1
1
Electrical Power Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
465
465
No Known Impact Or Consequence To Patient
449
449
No Consequences Or Impact To Patient
150
150
Failure of Implant
75
75
Injury
66
66
Cerebrospinal Fluid Leakage
51
51
Insufficient Information
46
46
No Information
46
46
Unspecified Infection
23
23
Device Embedded In Tissue or Plaque
13
13
Death
12
12
Hematoma
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Hemorrhage/Bleeding
9
9
No Code Available
9
9
Headache
9
9
Patient Problem/Medical Problem
8
8
Unspecified Tissue Injury
8
8
Neurological Deficit/Dysfunction
7
7
Fever
7
7
Intracranial Hemorrhage
6
6
Foreign Body In Patient
6
6
Hydrocephalus
5
5
No Patient Involvement
5
5
Not Applicable
4
4
Bacterial Infection
4
4
Brain Injury
3
3
Hernia
3
3
Therapeutic Effects, Unexpected
3
3
Coma
3
3
Ischemia
2
2
Test Result
2
2
Complaint, Ill-Defined
2
2
Impaired Healing
2
2
Vomiting
2
2
Pain
2
2
Paralysis
2
2
Contusion
2
2
Edema
2
2
Death, Intrauterine Fetal
1
1
Necrosis
1
1
Tissue Damage
1
1
Urinary Retention
1
1
Visual Impairment
1
1
Twitching
1
1
Meningitis
1
1
Breast Neoplasm
1
1
Vascular System (Circulation), Impaired
1
1
Missing Value Reason
1
1
Unspecified Nervous System Problem
1
1
Hemorrhage, Cerebral
1
1
Swelling
1
1
Neck Stiffness
1
1
Respiratory Failure
1
1
Fluid Discharge
1
1
Convulsion/Seizure
1
1
Seizures
1
1
Weakness
1
1
Burning Sensation
1
1
Hemorrhage, Subarachnoid
1
1
Ventilator Dependent
1
1
Post Operative Wound Infection
1
1
High Oxygen Saturation
1
1
Shaking/Tremors
1
1
Cardiac Arrest
1
1
Muscle Weakness
1
1
Perforation
1
1
Staphylococcus Aureus
1
1
Hemorrhage, Intraventricular
1
1
Fatigue
1
1
Ambulation Difficulties
1
1
Cognitive Changes
1
1
Cough
1
1
Air Embolism
1
1
Numbness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
I
Jul-22-2022
2
Integra LifeSciences Corp.
II
Oct-12-2019
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