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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 6
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 400 400

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2055 2055
Mechanical Problem 900 900
Obstruction of Flow 775 777
Insufficient Information 652 652
Break 651 651
Adverse Event Without Identified Device or Use Problem 376 377
Fluid/Blood Leak 343 344
Physical Resistance/Sticking 314 314
Fracture 291 292
Complete Blockage 266 266
Mechanics Altered 137 137
Output Problem 101 103
Leak/Splash 95 95
Pressure Problem 91 91
Crack 89 89
Device Difficult to Program or Calibrate 83 83
Disconnection 77 77
Mechanical Jam 70 70
Migration 66 66
No Flow 55 55
Material Split, Cut or Torn 49 49
Appropriate Term/Code Not Available 41 41
Device Dislodged or Dislocated 37 40
Excess Flow or Over-Infusion 35 35
Product Quality Problem 34 34
Insufficient Flow or Under Infusion 32 32
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Material Integrity Problem 30 30
Improper Flow or Infusion 28 28
Connection Problem 26 26
Detachment of Device or Device Component 25 25
Failure to Align 24 24
Use of Device Problem 24 24
Material Separation 20 20
Microbial Contamination of Device 20 20
Material Fragmentation 16 16
Loose or Intermittent Connection 16 17
Separation Problem 16 16
No Device Output 15 15
Positioning Problem 14 14
Material Twisted/Bent 13 13
Entrapment of Device 13 13
Material Frayed 12 12
Material Puncture/Hole 12 12
Patient Device Interaction Problem 12 12
Inappropriate or Unexpected Reset 11 11
Migration or Expulsion of Device 10 10
Difficult to Insert 9 9
Difficult to Remove 9 9
Unintended Movement 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2552 2552
No Clinical Signs, Symptoms or Conditions 1742 1743
Insufficient Information 771 771
Headache 292 300
Failure of Implant 226 232
Unspecified Infection 190 191
Cerebral Ventriculomeglia 174 174
Cerebrospinal Fluid Leakage 137 145
Unspecified Tissue Injury 129 129
Vomiting 105 105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 81 89
Bacterial Infection 78 78
Ambulation Difficulties 73 73
Intracranial Hemorrhage 73 73
Hematoma 70 70
Foreign Body In Patient 64 64
Convulsion/Seizure 63 63
Injury 58 58
Dizziness 53 53
Fever 48 48
Nausea 48 50
Hemorrhage/Bleeding 45 45
Pain 44 46
Confusion/ Disorientation 44 44
Swelling/ Edema 41 41
Cognitive Changes 40 40
Visual Impairment 33 33
Meningitis 28 28
Fatigue 26 26
Lethargy 22 22
Abdominal Pain 22 22
Loss of consciousness 21 21
Device Embedded In Tissue or Plaque 20 21
Coma 20 20
No Known Impact Or Consequence To Patient 20 20
Brain Injury 17 17
Memory Loss/Impairment 17 17
Seroma 16 16
Cyst(s) 16 16
Blurred Vision 16 16
Discomfort 15 15
Unspecified Nervous System Problem 14 14
Irritability 14 14
Impaired Healing 13 19
High Blood Pressure/ Hypertension 13 13
Cerebral Edema 12 12
Inflammation 12 12
Hearing Impairment 12 12
Post Operative Wound Infection 12 12
Dysphasia 11 11

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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