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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shunt, central nervous system and components
Product CodeJXG
Regulation Number 882.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
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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