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Device
shunt, central nervous system and components
Regulation Description
Central nervous system fluid shunt and components.
Product Code
JXG
Regulation Number
882.5550
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESCULAP INC.
SUBSTANTIALLY EQUIVALENT
1
AESCULAP, INC.
SUBSTANTIALLY EQUIVALENT
1
ANUNCIA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
BORVO MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
SUBSTANTIALLY EQUIVALENT
4
IRRAS USA
SUBSTANTIALLY EQUIVALENT
1
IRRAS USA INC.
SUBSTANTIALLY EQUIVALENT
2
JMED(SHENZHEN) TECHNOLOGY LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC NEUROSURGERY
SUBSTANTIALLY EQUIVALENT
2
SOPHYSA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1206
1206
2021
1467
1467
2022
1329
1330
2023
1221
1221
2024
1215
1215
2025
263
263
Device Problems
MDRs with this Device Problem
Events in those MDRs
Infusion or Flow Problem
2309
2309
Mechanical Problem
984
984
Insufficient Information
596
596
Obstruction of Flow
525
525
Break
469
469
Adverse Event Without Identified Device or Use Problem
451
451
Fluid/Blood Leak
321
321
Complete Blockage
239
239
Fracture
235
235
Mechanics Altered
135
135
Output Problem
107
107
Physical Resistance/Sticking
106
106
Pressure Problem
99
99
Leak/Splash
88
88
Appropriate Term/Code Not Available
84
84
Crack
82
82
Device Difficult to Program or Calibrate
69
69
Migration
67
67
Mechanical Jam
62
62
Electrical /Electronic Property Problem
55
55
Disconnection
53
53
Material Split, Cut or Torn
47
47
No Flow
38
38
Material Integrity Problem
37
37
Insufficient Flow or Under Infusion
35
35
Excess Flow or Over-Infusion
34
34
Device Dislodged or Dislocated
34
34
Product Quality Problem
33
33
Incorrect, Inadequate or Imprecise Result or Readings
29
29
Device Misassembled During Manufacturing /Shipping
23
23
Material Separation
22
22
Positioning Problem
22
22
Detachment of Device or Device Component
21
21
Defective Device
21
21
Use of Device Problem
19
19
Separation Problem
18
18
Improper Flow or Infusion
18
18
Activation, Positioning or Separation Problem
17
17
No Device Output
16
16
Material Fragmentation
14
14
Loose or Intermittent Connection
14
14
Migration or Expulsion of Device
13
13
Microbial Contamination of Device
13
13
Defective Component
13
13
Inappropriate or Unexpected Reset
11
11
Difficult to Remove
11
11
Material Twisted/Bent
11
11
Unintended Movement
11
11
Increase in Pressure
11
11
Material Frayed
10
10
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hydrocephalus
2302
2302
No Clinical Signs, Symptoms or Conditions
1339
1339
Insufficient Information
598
598
Injury
410
410
Headache
321
321
No Known Impact Or Consequence To Patient
250
250
Unspecified Infection
225
225
Failure of Implant
223
223
Cerebral Ventriculomeglia
181
181
Cerebrospinal Fluid Leakage
142
142
Unspecified Tissue Injury
129
129
Vomiting
109
109
Ambulation Difficulties
87
87
Patient Problem/Medical Problem
86
86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
78
78
Hematoma
76
76
Bacterial Infection
67
67
Intracranial Hemorrhage
60
60
Convulsion/Seizure
52
52
Dizziness
51
51
Fever
50
50
Confusion/ Disorientation
48
48
Foreign Body In Patient
48
48
Nausea
47
47
Pain
46
46
Therapeutic Effects, Unexpected
43
43
Swelling/ Edema
39
39
Hemorrhage/Bleeding
39
39
Cognitive Changes
38
38
No Consequences Or Impact To Patient
36
36
Visual Impairment
34
34
Meningitis
28
28
Coma
27
27
Device Embedded In Tissue or Plaque
25
25
Fatigue
24
24
Loss of consciousness
24
24
Lethargy
20
20
Brain Injury
18
18
Blurred Vision
18
18
Seroma
18
18
Discomfort
16
16
Cyst(s)
16
16
Irritability
15
15
Abdominal Pain
14
14
Memory Loss/Impairment
13
13
No Code Available
13
13
Impaired Healing
13
13
Dysphasia
13
13
Unspecified Nervous System Problem
13
13
Hypersensitivity/Allergic reaction
12
12
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
II
Jan-17-2025
2
Integra LifeSciences Corp.
II
Jun-12-2024
3
Integra LifeSciences Corp.
II
Dec-23-2020
4
Medtronic Neurosurgery
II
Aug-17-2023
5
Medtronic Neurosurgery
II
Feb-12-2021
6
Medtronic Neurosurgery
II
Jan-15-2021
7
Medtronic Neurosurgery
II
Dec-28-2020
8
Natus Manufacturing Limited
II
Feb-22-2021
9
Natus Medical Incorporated
II
Jan-04-2024
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