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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
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
MDR Year
MDR Reports
MDR Events
2019
260
260
2020
268
268
2021
211
211
2022
424
424
2023
746
746
2024
608
608
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
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
Smiths Medical ASD, Inc.
II
Oct-23-2024
6
Sophysa S.A.
II
May-15-2024
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