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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 2
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 2
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
2020 1206 1206
2021 1467 1470
2022 1329 1337
2023 1221 1221
2024 1214 1215
2025 1112 1112

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2412 2412
Mechanical Problem 996 996
Obstruction of Flow 702 704
Insufficient Information 689 689
Break 617 617
Adverse Event Without Identified Device or Use Problem 477 478
Fluid/Blood Leak 366 367
Fracture 281 282
Complete Blockage 278 278
Physical Resistance/Sticking 250 250
Mechanics Altered 151 151
Output Problem 112 114
Leak/Splash 106 106
Pressure Problem 99 99
Crack 96 96
Appropriate Term/Code Not Available 84 84
Device Difficult to Program or Calibrate 83 83
Disconnection 78 78
Mechanical Jam 76 76
Migration 73 73
Electrical /Electronic Property Problem 55 55
Material Split, Cut or Torn 51 51
No Flow 45 45
Material Integrity Problem 41 41
Excess Flow or Over-Infusion 39 39
Device Dislodged or Dislocated 38 41
Insufficient Flow or Under Infusion 37 37
Product Quality Problem 34 34
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Improper Flow or Infusion 30 30
Use of Device Problem 30 30
Detachment of Device or Device Component 26 26
Material Separation 26 26
Device Misassembled During Manufacturing /Shipping 25 25
Connection Problem 24 24
Positioning Problem 23 23
Defective Device 23 23
Material Fragmentation 20 20
Microbial Contamination of Device 18 18
Separation Problem 18 18
Activation, Positioning or Separation Problem 17 17
Loose or Intermittent Connection 17 18
No Device Output 16 16
Material Twisted/Bent 14 14
Defective Component 13 19
Migration or Expulsion of Device 13 13
Material Frayed 12 12
Material Puncture/Hole 12 12
Entrapment of Device 12 12
Failure to Align 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2572 2572
No Clinical Signs, Symptoms or Conditions 1640 1641
Insufficient Information 719 719
Injury 410 410
Headache 349 357
No Known Impact Or Consequence To Patient 250 250
Unspecified Infection 249 250
Failure of Implant 226 232
Cerebral Ventriculomeglia 188 188
Cerebrospinal Fluid Leakage 154 162
Unspecified Tissue Injury 129 129
Vomiting 122 122
Ambulation Difficulties 91 91
Patient Problem/Medical Problem 86 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 83 91
Hematoma 81 81
Bacterial Infection 78 78
Intracranial Hemorrhage 72 72
Foreign Body In Patient 66 66
Fever 60 60
Convulsion/Seizure 59 59
Dizziness 58 58
Nausea 53 55
Confusion/ Disorientation 51 51
Pain 49 51
Cognitive Changes 45 45
Hemorrhage/Bleeding 43 43
Therapeutic Effects, Unexpected 43 43
Swelling/ Edema 43 43
Visual Impairment 37 37
No Consequences Or Impact To Patient 36 36
Fatigue 30 30
Meningitis 29 29
Coma 29 29
Device Embedded In Tissue or Plaque 27 28
Loss of consciousness 26 26
Lethargy 25 25
Cyst(s) 23 23
Abdominal Pain 20 20
Blurred Vision 19 19
Seroma 19 19
Brain Injury 18 18
Memory Loss/Impairment 17 17
Discomfort 17 17
Irritability 16 16
Unspecified Nervous System Problem 14 14
Hypersensitivity/Allergic reaction 14 14
No Code Available 13 13
Impaired Healing 13 19
Dysphasia 13 13

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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