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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
Regulation Description Central nervous system fluid shunt and components.
Product CodeJXG
Regulation Number 882.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANUNCIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BORVO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAINSPACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
IRRAS USA
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
JMED(SHENZHEN) TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROSURGERY
  SUBSTANTIALLY EQUIVALENT 2
PHASOR HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
SOPHYSA
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 1467 1470
2022 1329 1337
2023 1221 1221
2024 1214 1215
2025 1219 1219
2026 691 691

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2096 2096
Mechanical Problem 899 899
Obstruction of Flow 833 833
Insufficient Device Problem Information 673 673
Break 646 646
Adverse Event Without Identified Device or Use Problem 388 388
Physical Resistance/Sticking 358 358
Fluid/Blood Leak 346 347
Fracture 303 304
Complete Blockage 273 273
Mechanics Altered 140 140
Output Problem 99 99
Leak/Splash 92 92
Pressure Problem 91 91
Crack 87 87
Device Difficult to Program or Calibrate 83 83
Disconnection 79 79
Mechanical Jam 73 73
Migration 69 69
No Flow 54 54
Material Split, Cut or Torn 49 49
Failure to Align 40 40
Appropriate Device Problem Term/Code Not Available 38 38
Excess Flow or Over-Infusion 35 35
Device Dislodged or Dislocated 34 35
Insufficient Flow or Under Infusion 32 32
Material Integrity Problem 32 32
Product Quality Problem 31 31
Incorrect, Inadequate or Imprecise Result or Readings 30 30
Improper Flow or Infusion 27 27
Connection Problem 24 24
Microbial Contamination of Device 21 21
Use of Device Problem 21 21
Detachment of Device or Device Component 19 19
No Device Output 16 16
Loose or Intermittent Connection 16 17
Separation Problem 16 16
Material Separation 15 15
Material Fragmentation 15 15
Unintended System Motion 13 13
Material Twisted/Bent 11 11
Positioning Problem 11 11
Migration or Expulsion of Device 10 10
Contamination 10 10
Patient Device Interaction Problem 10 10
Inappropriate or Unexpected Reset 10 10
Difficult to Insert 9 9
Retraction Problem 8 8
Device Unsafe to Use in Environment 8 8
Material Frayed 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2654 2654
No Clinical Signs, Symptoms or Conditions 1834 1835
Insufficient Information 811 811
Headache 304 312
Failure of Implant 226 232
Unspecified Infection 201 202
Cerebral Ventriculomegaly 177 177
Cerebrospinal Fluid Leakage 139 147
Unspecified Tissue Injury 130 130
Vomiting 105 105
Bacterial Infection 84 84
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 82 90
Intracranial Hemorrhage 79 79
Hematoma 77 77
Ambulation or Postural Difficulties 75 75
Convulsion/Seizure 67 67
Foreign Body In Patient 66 66
Injury 58 58
Dizziness 53 53
Fever 50 50
Nausea 48 50
Hemorrhage/Blood Loss/Bleeding 45 45
Confusion/ Disorientation 44 44
Pain 44 46
Swelling/ Edema 43 43
Cognitive Changes 41 41
Visual Impairment 33 33
Meningitis 29 29
Loss of consciousness 28 28
Fatigue 27 27
Abdominal Pain 24 24
Lethargy 23 23
Device Embedded In Tissue or Plaque 21 22
No Known Impact Or Consequence To Patient 20 20
Coma 20 20
Seroma 17 17
Brain Injury 17 17
Memory Loss/Impairment 17 17
Discomfort 17 17
Cyst(s) 16 16
Blurred Vision 16 16
Irritability 14 14
Pneumocephalus 14 15
Unspecified Nervous System Problem 14 14
Post Operative Wound Infection 13 13
High Blood Pressure/ Hypertension 13 13
Inflammation 13 13
Impaired Healing 13 19
Balance Problems 12 12
Hearing Impairment 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. (NeuroSciences) II May-13-2026
4 Medtronic Neurosurgery II Aug-17-2023
5 Medtronic Neurosurgery II Feb-12-2021
6 Medtronic Neurosurgery II Jan-15-2021
7 Natus Manufacturing Limited II Feb-22-2021
8 Natus Medical Incorporated II Jan-04-2024
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