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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
INTEGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
SUBSTANTIALLY EQUIVALENT
4
IRRAS USA
SUBSTANTIALLY EQUIVALENT
1
IRRAS USA INC.
SUBSTANTIALLY EQUIVALENT
2
IRRAS USA, LTD.
SUBSTANTIALLY EQUIVALENT
1
JMED(SHENZHEN) TECHNOLOGY LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC NEUROSURGERY
SUBSTANTIALLY EQUIVALENT
1
SOPHYSA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1295
1295
2020
1206
1206
2021
1467
1467
2022
1329
1330
2023
1221
1221
2024
264
264
Device Problems
MDRs with this Device Problem
Events in those MDRs
Infusion or Flow Problem
2190
2190
Mechanical Problem
946
946
Insufficient Information
620
620
Obstruction of Flow
574
574
Adverse Event Without Identified Device or Use Problem
516
516
Break
470
470
Fluid/Blood Leak
313
313
Appropriate Term/Code Not Available
228
228
Fracture
210
210
Complete Blockage
203
203
Mechanics Altered
121
121
Pressure Problem
113
113
Output Problem
104
104
Device Difficult to Program or Calibrate
86
86
Leak/Splash
83
83
Crack
76
76
Disconnection
66
66
Electrical /Electronic Property Problem
65
65
Migration
65
65
Mechanical Jam
57
57
Material Integrity Problem
47
47
Material Split, Cut or Torn
45
45
Device Dislodged or Dislocated
41
41
No Flow
40
40
Detachment of Device or Device Component
33
33
Insufficient Flow or Under Infusion
29
29
Defective Device
28
28
Incorrect, Inadequate or Imprecise Result or Readings
27
27
Separation Problem
27
27
Material Separation
25
25
Excess Flow or Over-Infusion
25
25
Improper Flow or Infusion
24
24
Device Misassembled During Manufacturing /Shipping
23
23
Use of Device Problem
22
22
Material Fragmentation
21
21
Activation, Positioning or Separation Problem
20
20
Positioning Problem
20
20
Loose or Intermittent Connection
19
19
No Device Output
17
17
Defective Component
17
17
Migration or Expulsion of Device
15
15
Difficult to Remove
12
12
Increase in Pressure
11
11
Material Twisted/Bent
11
11
Therapeutic or Diagnostic Output Failure
11
11
Unintended Movement
11
11
Material Puncture/Hole
10
10
Device Appears to Trigger Rejection
10
10
Manufacturing, Packaging or Shipping Problem
9
9
Physical Resistance/Sticking
9
9
Excessive Heating
9
9
Product Quality Problem
8
8
Retraction Problem
8
8
Overheating of Device
8
8
Partial Blockage
7
7
Microbial Contamination of Device
7
7
Malposition of Device
7
7
Patient Device Interaction Problem
7
7
No Apparent Adverse Event
6
6
Reset Problem
6
6
Failure to Advance
6
6
Component Missing
6
6
Material Deformation
6
6
Inappropriate or Unexpected Reset
6
6
Free or Unrestricted Flow
6
6
Gas/Air Leak
6
7
Contamination
6
6
Entrapment of Device
6
6
Material Frayed
5
5
Decrease in Pressure
5
5
Material Rupture
5
5
Failure to Read Input Signal
5
5
Device Unsafe to Use in Environment
5
5
Device Markings/Labelling Problem
5
5
Connection Problem
5
5
Patient-Device Incompatibility
5
5
Device Fell
5
5
Audible Prompt/Feedback Problem
4
4
Packaging Problem
4
4
Communication or Transmission Problem
4
4
Material Protrusion/Extrusion
4
4
Loss of or Failure to Bond
4
4
Calcified
4
4
Difficult to Insert
3
3
Labelling, Instructions for Use or Training Problem
3
3
Incorrect Measurement
3
3
Device Slipped
3
3
Unable to Obtain Readings
3
3
Material Discolored
3
3
Nonstandard Device
3
3
Delivered as Unsterile Product
3
3
Difficult to Advance
3
3
Application Program Problem
3
3
Expiration Date Error
3
3
Unexpected Therapeutic Results
3
3
Fitting Problem
3
3
Program or Algorithm Execution Failure
3
3
Noise, Audible
3
3
Device Contaminated at the User Facility
2
2
Lack of Effect
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hydrocephalus
2022
2022
No Clinical Signs, Symptoms or Conditions
959
959
No Known Impact Or Consequence To Patient
555
555
Failure of Implant
554
554
Injury
513
513
Insufficient Information
422
422
Headache
338
338
Unspecified Infection
254
254
Patient Problem/Medical Problem
173
173
Cerebral Ventriculomeglia
169
169
Cerebrospinal Fluid Leakage
167
167
Unspecified Tissue Injury
125
125
No Consequences Or Impact To Patient
108
108
Vomiting
106
106
Therapeutic Effects, Unexpected
103
103
Ambulation Difficulties
86
86
Hematoma
79
79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
76
76
Bacterial Infection
63
63
Intracranial Hemorrhage
53
53
Fever
52
52
Pain
51
51
Nausea
48
48
Cognitive Changes
46
46
Confusion/ Disorientation
45
45
Dizziness
45
45
Convulsion/Seizure
44
44
Foreign Body In Patient
38
38
Coma
37
37
Hemorrhage/Bleeding
36
36
Visual Impairment
34
34
Swelling/ Edema
30
30
Device Embedded In Tissue or Plaque
29
29
Fatigue
29
29
Meningitis
24
24
Death
23
23
No Code Available
23
23
Lethargy
22
22
Loss of consciousness
20
20
Brain Injury
19
19
Blurred Vision
18
18
Complaint, Ill-Defined
18
18
Seroma
18
18
Swelling
17
18
Hypersensitivity/Allergic reaction
17
17
Neurological Deficit/Dysfunction
16
16
Dysphasia
15
15
Hemorrhage, Subdural
15
15
Cyst(s)
15
15
Abdominal Pain
15
15
Irritability
14
14
Discomfort
13
13
High Blood Pressure/ Hypertension
13
13
Memory Loss/Impairment
13
13
Impaired Healing
13
13
No Information
13
13
Unspecified Nervous System Problem
13
13
Paralysis
12
12
Wound Dehiscence
12
12
Inflammation
11
11
Post Operative Wound Infection
11
11
Seizures
11
11
Loss of Vision
11
11
Urinary Tract Infection
10
10
Pneumonia
10
10
Malaise
10
10
Incontinence
10
10
Hearing Impairment
10
10
Laceration(s)
9
9
Arrhythmia
9
9
Erythema
9
9
Respiratory Failure
9
9
Emotional Changes
8
8
Adhesion(s)
8
8
Abscess
7
7
Erosion
7
7
Stroke/CVA
7
7
Paresis
7
7
Therapeutic Response, Decreased
7
7
Obstruction/Occlusion
7
7
Visual Disturbances
7
7
Sleep Dysfunction
7
7
Cerebral Edema
7
7
Fluid Discharge
7
7
Thrombosis/Thrombus
7
7
Bowel Perforation
6
6
Tinnitus
6
6
Loss of Range of Motion
6
6
Rash
6
6
Depression
6
6
Muscle Weakness
6
6
Diarrhea
6
6
Fall
6
6
Dysphagia/ Odynophagia
5
5
Head Injury
5
5
Fistula
5
5
Urinary Frequency
5
5
Local Reaction
5
5
Weakness
5
5
Balance Problems
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
II
Dec-23-2020
2
Integra LifeSciences Corp.
I
May-20-2019
3
Medtronic Neurosurgery
II
Aug-17-2023
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
8
Natus Medical Incorporated
II
Jan-04-2024
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