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TPLC
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Device
shunt, central nervous system and components
Product Code
JXG
Regulation Number
882.5550
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESCULAP, INC.
SUBSTANTIALLY EQUIVALENT
3
ANUNCIA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
AQUEDUCT CRITICAL CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
BTG INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES CORP.
SUBSTANTIALLY EQUIVALENT
2
INTEGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
SUBSTANTIALLY EQUIVALENT
2
IRRAS INC.
SUBSTANTIALLY EQUIVALENT
1
IRRAS USA
SUBSTANTIALLY EQUIVALENT
1
IRRAS USA INC.
SUBSTANTIALLY EQUIVALENT
1
IRRAS USA, LTD.
SUBSTANTIALLY EQUIVALENT
1
JMED(SHENZHEN) TECHNOLOGY LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC NEUROSURGERY
SUBSTANTIALLY EQUIVALENT
2
SOPHYSA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1483
1483
2019
1295
1295
2020
1206
1206
2021
1467
1467
2022
1330
1333
2023
358
358
Device Problems
MDRs with this Device Problem
Events in those MDRs
Infusion or Flow Problem
1825
1825
Mechanical Problem
847
847
Obstruction of Flow
669
669
Insufficient Information
645
645
Adverse Event Without Identified Device or Use Problem
552
552
Break
485
485
Appropriate Term/Code Not Available
417
417
Fluid/Blood Leak
327
327
Fracture
200
200
Device Operates Differently Than Expected
177
177
Complete Blockage
172
172
Mechanics Altered
152
152
Pressure Problem
113
113
Output Problem
103
103
Device Difficult to Program or Calibrate
98
98
Crack
79
79
Disconnection
79
79
Device Dislodged or Dislocated
76
76
Leak/Splash
75
75
Migration
74
74
Electrical /Electronic Property Problem
65
65
Mechanical Jam
61
61
Material Integrity Problem
46
46
Material Separation
46
46
Material Split, Cut or Torn
42
42
No Flow
41
41
Detachment of Device or Device Component
41
41
Defective Device
38
38
Partial Blockage
38
38
Excess Flow or Over-Infusion
34
34
Migration or Expulsion of Device
31
31
Insufficient Flow or Under Infusion
29
29
Material Fragmentation
28
28
Programming Issue
27
27
Use of Device Problem
26
26
Improper Flow or Infusion
25
25
Device Misassembled During Manufacturing /Shipping
24
24
Blocked Connection
24
24
Incorrect, Inadequate or Imprecise Result or Readings
24
24
Separation Problem
24
24
Activation, Positioning or Separation Problem
22
22
Defective Component
22
22
Occlusion Within Device
20
20
Positioning Problem
18
18
Loose or Intermittent Connection
17
17
No Device Output
14
14
Overcorrection
14
14
Material Twisted/Bent
14
14
Overheating of Device
13
13
Material Puncture/Hole
13
13
Increase in Pressure
12
12
Device Operational Issue
12
12
Difficult to Remove
11
11
Patient-Device Incompatibility
10
10
Device Appears to Trigger Rejection
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Physical Resistance/Sticking
10
10
Therapeutic or Diagnostic Output Failure
9
9
Restricted Flow rate
9
9
Retraction Problem
8
8
Product Quality Problem
8
8
Free or Unrestricted Flow
8
8
Unintended Movement
8
8
Excessive Heating
8
8
No Apparent Adverse Event
7
7
Reset Problem
7
7
Material Deformation
7
7
Inappropriate or Unexpected Reset
7
7
Malposition of Device
7
7
Device Markings/Labelling Problem
7
7
Failure to Advance
7
7
Misassembled
7
7
Unable to Obtain Readings
6
6
Nonstandard Device
5
5
Material Discolored
5
5
Material Frayed
5
5
Entrapment of Device
5
5
Calcified
5
5
Detachment Of Device Component
5
5
Component Missing
5
5
Material Rupture
5
5
Separation Failure
5
5
Gas/Air Leak
5
6
Material Protrusion/Extrusion
5
5
Device Fell
5
5
Missing Information
4
4
Device Contaminated at the User Facility
4
6
Patient Device Interaction Problem
4
4
Failure to Auto Stop
4
4
Application Program Problem
4
4
Communication or Transmission Problem
4
4
Connection Problem
4
4
Loss of or Failure to Bond
4
4
Use of Incorrect Control/Treatment Settings
4
4
Incorrect Measurement
4
4
Failure to Prime
4
4
Decrease in Pressure
3
3
Labelling, Instructions for Use or Training Problem
3
3
Flushing Problem
3
3
Delivered as Unsterile Product
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hydrocephalus
1732
1732
No Known Impact Or Consequence To Patient
1167
1167
No Clinical Signs, Symptoms or Conditions
705
705
Failure of Implant
656
656
Injury
529
529
Headache
371
371
Unspecified Infection
300
300
Insufficient Information
233
233
No Information
203
203
Cerebrospinal Fluid Leakage
194
194
Patient Problem/Medical Problem
178
178
Therapeutic Effects, Unexpected
161
161
No Consequences Or Impact To Patient
148
148
Cerebral Ventriculomeglia
135
135
Vomiting
123
123
Ambulation Difficulties
110
110
Hematoma
83
83
Unspecified Tissue Injury
80
80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
63
63
Dizziness
63
63
Pain
61
61
Nausea
61
61
Cognitive Changes
61
61
No Code Available
57
57
Neurological Deficit/Dysfunction
55
55
Complaint, Ill-Defined
54
54
Fever
52
52
Bacterial Infection
51
51
Confusion/ Disorientation
41
41
Coma
40
40
Fatigue
39
39
Intracranial Hemorrhage
39
39
Visual Impairment
37
37
Device Embedded In Tissue or Plaque
36
36
Foreign Body In Patient
34
34
Therapeutic Response, Decreased
33
33
Death
33
33
Hemorrhage/Bleeding
32
32
Convulsion/Seizure
31
31
Swelling
29
30
Seizures
26
26
Lethargy
23
23
Loss of consciousness
23
23
Seroma
22
22
Blurred Vision
22
22
Hemorrhage, Subdural
22
22
Swelling/ Edema
21
21
Dysphasia
20
20
Meningitis
20
20
Cyst(s)
19
19
Abdominal Pain
17
17
Incontinence
17
17
Hypersensitivity/Allergic reaction
16
16
Irritability
16
16
Discomfort
16
16
Brain Injury
16
16
Impaired Healing
15
15
Memory Loss/Impairment
14
14
Muscle Weakness
14
14
Wound Dehiscence
13
13
Erosion
13
13
Malaise
13
13
Inflammation
12
12
Hemorrhage, Cerebral
11
11
Hearing Impairment
11
11
Post Operative Wound Infection
11
11
Unspecified Nervous System Problem
11
11
Edema
10
10
Weakness
10
10
Loss of Vision
10
10
Vertigo
10
10
Urinary Tract Infection
10
10
Visual Disturbances
9
9
Staphylococcus Aureus
9
9
No Patient Involvement
9
9
Pneumonia
8
8
Paralysis
8
8
Paresis
8
8
Tissue Damage
8
8
Emotional Changes
8
8
Dysphagia/ Odynophagia
8
8
Abscess
8
8
Adhesion(s)
8
8
Hemorrhage, Intraventricular
8
8
High Blood Pressure/ Hypertension
8
8
Laceration(s)
8
8
Arrhythmia
7
7
Erythema
7
7
Tinnitus
7
7
Obstruction/Occlusion
7
7
Bowel Perforation
7
7
Tissue Breakdown
7
7
Fluid Discharge
7
7
Neck Stiffness
7
7
Respiratory Failure
7
7
Cerebral Edema
7
7
Sleep Dysfunction
6
6
Encephalitis
6
8
Numbness
6
6
Depression
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Mar-01-2018
2
Integra LifeSciences Corp.
II
Dec-23-2020
3
Integra LifeSciences Corp.
I
May-20-2019
4
Medtronic Neurosurgery
II
Feb-12-2021
5
Medtronic Neurosurgery
II
Jan-15-2021
6
Medtronic Neurosurgery
II
Dec-28-2020
7
Natus Manufacturing Limited
II
Feb-22-2021
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