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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
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANUNCIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BORVO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
IRRAS USA
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA INC.
  SUBSTANTIALLY EQUIVALENT 2
JMED(SHENZHEN) TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROSURGERY
  SUBSTANTIALLY EQUIVALENT 2
SOPHYSA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1206 1206
2021 1467 1467
2022 1329 1330
2023 1221 1221
2024 1215 1215
2025 263 263

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2309 2309
Mechanical Problem 984 984
Insufficient Information 596 596
Obstruction of Flow 525 525
Break 469 469
Adverse Event Without Identified Device or Use Problem 451 451
Fluid/Blood Leak 321 321
Complete Blockage 239 239
Fracture 235 235
Mechanics Altered 135 135
Output Problem 107 107
Physical Resistance/Sticking 106 106
Pressure Problem 99 99
Leak/Splash 88 88
Appropriate Term/Code Not Available 84 84
Crack 82 82
Device Difficult to Program or Calibrate 69 69
Migration 67 67
Mechanical Jam 62 62
Electrical /Electronic Property Problem 55 55
Disconnection 53 53
Material Split, Cut or Torn 47 47
No Flow 38 38
Material Integrity Problem 37 37
Insufficient Flow or Under Infusion 35 35
Excess Flow or Over-Infusion 34 34
Device Dislodged or Dislocated 34 34
Product Quality Problem 33 33
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Device Misassembled During Manufacturing /Shipping 23 23
Material Separation 22 22
Positioning Problem 22 22
Detachment of Device or Device Component 21 21
Defective Device 21 21
Use of Device Problem 19 19
Separation Problem 18 18
Improper Flow or Infusion 18 18
Activation, Positioning or Separation Problem 17 17
No Device Output 16 16
Material Fragmentation 14 14
Loose or Intermittent Connection 14 14
Migration or Expulsion of Device 13 13
Microbial Contamination of Device 13 13
Defective Component 13 13
Inappropriate or Unexpected Reset 11 11
Difficult to Remove 11 11
Material Twisted/Bent 11 11
Unintended Movement 11 11
Increase in Pressure 11 11
Material Frayed 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2302 2302
No Clinical Signs, Symptoms or Conditions 1339 1339
Insufficient Information 598 598
Injury 410 410
Headache 321 321
No Known Impact Or Consequence To Patient 250 250
Unspecified Infection 225 225
Failure of Implant 223 223
Cerebral Ventriculomeglia 181 181
Cerebrospinal Fluid Leakage 142 142
Unspecified Tissue Injury 129 129
Vomiting 109 109
Ambulation Difficulties 87 87
Patient Problem/Medical Problem 86 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 78
Hematoma 76 76
Bacterial Infection 67 67
Intracranial Hemorrhage 60 60
Convulsion/Seizure 52 52
Dizziness 51 51
Fever 50 50
Confusion/ Disorientation 48 48
Foreign Body In Patient 48 48
Nausea 47 47
Pain 46 46
Therapeutic Effects, Unexpected 43 43
Swelling/ Edema 39 39
Hemorrhage/Bleeding 39 39
Cognitive Changes 38 38
No Consequences Or Impact To Patient 36 36
Visual Impairment 34 34
Meningitis 28 28
Coma 27 27
Device Embedded In Tissue or Plaque 25 25
Fatigue 24 24
Loss of consciousness 24 24
Lethargy 20 20
Brain Injury 18 18
Blurred Vision 18 18
Seroma 18 18
Discomfort 16 16
Cyst(s) 16 16
Irritability 15 15
Abdominal Pain 14 14
Memory Loss/Impairment 13 13
No Code Available 13 13
Impaired Healing 13 13
Dysphasia 13 13
Unspecified Nervous System Problem 13 13
Hypersensitivity/Allergic reaction 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. II Dec-23-2020
4 Medtronic Neurosurgery II Aug-17-2023
5 Medtronic Neurosurgery II Feb-12-2021
6 Medtronic Neurosurgery II Jan-15-2021
7 Medtronic Neurosurgery II Dec-28-2020
8 Natus Manufacturing Limited II Feb-22-2021
9 Natus Medical Incorporated II Jan-04-2024
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