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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 793 793

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2108 2108
Mechanical Problem 899 899
Obstruction of Flow 858 858
Insufficient Device Problem Information 682 682
Break 655 655
Adverse Event Without Identified Device or Use Problem 388 388
Physical Resistance/Sticking 372 372
Fluid/Blood Leak 351 352
Fracture 310 311
Complete Blockage 277 277
Mechanics Altered 143 143
Output Problem 99 99
Leak/Splash 93 93
Pressure Problem 91 91
Crack 91 91
Device Difficult to Program or Calibrate 86 86
Disconnection 81 81
Migration 77 77
Mechanical Jam 75 75
No Flow 54 54
Material Split, Cut or Torn 51 51
Failure to Align 44 44
Device Dislodged or Dislocated 41 42
Appropriate Device Problem Term/Code Not Available 38 38
Excess Flow or Over-Infusion 35 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 29 29
Connection Problem 24 24
Use of Device Problem 21 21
Microbial Contamination of Device 21 21
Detachment of Device or Device Component 21 21
No Device Output 16 16
Material Separation 16 16
Loose or Intermittent Connection 16 17
Separation Problem 16 16
Material Fragmentation 15 15
Unintended System Motion 15 15
Material Twisted/Bent 11 11
Positioning Problem 11 11
Inappropriate or Unexpected Reset 10 10
Patient Device Interaction Problem 10 10
Migration or Expulsion of Device 10 10
Contamination 10 10
Difficult to Insert 9 9
Material Frayed 8 8
Restricted Flow rate 8 8
Retraction Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2688 2688
No Clinical Signs, Symptoms or Conditions 1861 1862
Insufficient Information 834 834
Headache 312 320
Failure of Implant 226 232
Unspecified Infection 207 208
Cerebral Ventriculomegaly 177 177
Cerebrospinal Fluid Leakage 139 147
Unspecified Tissue Injury 130 130
Vomiting 105 105
Bacterial Infection 87 87
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 82 90
Intracranial Hemorrhage 81 81
Hematoma 78 78
Ambulation or Postural Difficulties 78 78
Foreign Body In Patient 68 68
Convulsion/Seizure 67 67
Injury 58 58
Dizziness 55 55
Fever 52 52
Nausea 49 51
Pain 46 48
Hemorrhage/Blood Loss/Bleeding 46 46
Confusion/ Disorientation 45 45
Cognitive Changes 44 44
Swelling/ Edema 43 43
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
Coma 20 20
No Known Impact Or Consequence To Patient 20 20
Blurred Vision 19 19
Memory Loss/Impairment 18 18
Seroma 18 18
Brain Injury 17 17
Discomfort 17 17
Cyst(s) 16 16
Unspecified Nervous System Problem 14 14
Pneumocephalus 14 15
Irritability 14 14
Post Operative Wound Infection 13 13
Inflammation 13 13
Impaired Healing 13 19
High Blood Pressure/ Hypertension 13 13
Cerebral Edema 12 12
Wound Dehiscence 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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