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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
Product CodeJXG
Regulation Number 882.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 3
ANUNCIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BORVO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
IRRAS USA
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA INC.
  SUBSTANTIALLY EQUIVALENT 2
IRRAS USA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
JMED(SHENZHEN) TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROSURGERY
  SUBSTANTIALLY EQUIVALENT 1
SOPHYSA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1295 1295
2020 1206 1206
2021 1467 1467
2022 1329 1330
2023 1221 1221
2024 984 984

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2421 2421
Mechanical Problem 1080 1080
Insufficient Information 682 682
Obstruction of Flow 611 611
Break 529 529
Adverse Event Without Identified Device or Use Problem 524 524
Fluid/Blood Leak 356 356
Appropriate Term/Code Not Available 230 230
Fracture 229 229
Complete Blockage 221 221
Mechanics Altered 148 148
Pressure Problem 120 120
Output Problem 105 105
Leak/Splash 100 100
Device Difficult to Program or Calibrate 94 94
Crack 84 84
Disconnection 75 75
Migration 73 73
Mechanical Jam 68 68
Electrical /Electronic Property Problem 65 65
Material Split, Cut or Torn 50 50
No Flow 49 49
Material Integrity Problem 48 48
Device Dislodged or Dislocated 44 44
Product Quality Problem 36 36
Detachment of Device or Device Component 35 35
Insufficient Flow or Under Infusion 33 33
Excess Flow or Over-Infusion 33 33
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Material Separation 28 28
Defective Device 28 28
Separation Problem 27 27
Improper Flow or Infusion 27 27
Use of Device Problem 25 25
Device Misassembled During Manufacturing /Shipping 23 23
Material Fragmentation 23 23
Loose or Intermittent Connection 22 22
Positioning Problem 21 21
Activation, Positioning or Separation Problem 20 20
Defective Component 17 17
No Device Output 17 17
Migration or Expulsion of Device 15 15
Physical Resistance/Sticking 15 15
Material Twisted/Bent 13 13
Material Puncture/Hole 12 12
Unintended Movement 12 12
Difficult to Remove 12 12
Material Frayed 11 11
Increase in Pressure 11 11
Therapeutic or Diagnostic Output Failure 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2300 2300
No Clinical Signs, Symptoms or Conditions 1173 1173
Failure of Implant 558 558
No Known Impact Or Consequence To Patient 555 555
Insufficient Information 536 536
Injury 513 513
Headache 358 358
Unspecified Infection 265 265
Cerebrospinal Fluid Leakage 178 178
Cerebral Ventriculomeglia 175 175
Patient Problem/Medical Problem 173 173
Unspecified Tissue Injury 129 129
Vomiting 122 122
No Consequences Or Impact To Patient 108 108
Therapeutic Effects, Unexpected 103 103
Ambulation Difficulties 94 94
Hematoma 84 84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 77 77
Bacterial Infection 72 72
Fever 56 56
Intracranial Hemorrhage 56 56
Dizziness 56 56
Pain 55 55
Nausea 52 52
Confusion/ Disorientation 49 49
Cognitive Changes 48 48
Foreign Body In Patient 47 47
Convulsion/Seizure 47 47
Hemorrhage/Bleeding 40 40
Coma 38 38
Visual Impairment 36 36
Device Embedded In Tissue or Plaque 33 33
Fatigue 33 33
Swelling/ Edema 31 31
Meningitis 28 28
Loss of consciousness 27 27
Lethargy 25 25
Death 23 23
No Code Available 23 23
Seroma 20 20
Brain Injury 19 19
Blurred Vision 18 18
Complaint, Ill-Defined 18 18
Cyst(s) 18 18
Hypersensitivity/Allergic reaction 17 17
Discomfort 17 17
Swelling 17 18
Abdominal Pain 16 16
Neurological Deficit/Dysfunction 16 16
Dysphasia 16 16

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Jun-12-2024
2 Integra LifeSciences Corp. II Dec-23-2020
3 Integra LifeSciences Corp. I May-20-2019
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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