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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 3
ALCYONE LIFESCIENCES. INC.
  SUBSTANTIALLY EQUIVALENT 1
AQUEDUCT CRITICAL CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
AQUEDUCT CRITICAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARKIS BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
BTG INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IRRAS INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROSURGERY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1333 1333
2018 1482 1482
2019 1295 1295
2020 1206 1206
2021 1467 1467

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 1208 1208
Adverse Event Without Identified Device or Use Problem 622 622
Obstruction of Flow 573 573
Mechanical Problem 560 560
Insufficient Information 490 490
Appropriate Term/Code Not Available 487 487
Break 464 464
Device Operates Differently Than Expected 411 411
Fluid Leak 252 252
Programming Issue 148 148
Leak/Splash 147 147
Occlusion Within Device 147 147
Mechanics Altered 128 128
Fracture 118 118
Device Difficult to Program or Calibrate 92 92
Device Dislodged or Dislocated 91 91
Disconnection 86 86
Complete Blockage 85 85
Partial Blockage 84 84
Device Operational Issue 83 83
Output Problem 78 78
Pressure Problem 75 75
Crack 74 74
Mechanical Jam 73 73
No Flow 68 68
Electrical /Electronic Property Problem 63 63
Inaccurate Flow Rate 61 61
Excess Flow or Over-Infusion 55 55
Migration 52 52
Migration or Expulsion of Device 49 49
Material Separation 47 47
Insufficient Flow or Under Infusion 45 45
Material Integrity Problem 43 43
Defective Device 42 42
Detachment of Device or Device Component 39 39
Improper Flow or Infusion 36 36
Blocked Connection 28 28
Use of Device Problem 25 25
Material Fragmentation 24 24
Separation Problem 23 23
Material Split, Cut or Torn 22 22
Device Misassembled During Manufacturing /Shipping 22 22
Activation, Positioning or SeparationProblem 20 20
Defective Component 20 20
Detachment Of Device Component 17 17
Overheating of Device 17 17
Incorrect, Inadequate or Imprecise Resultor Readings 17 17
Loose or Intermittent Connection 14 14
Overcorrection 14 14
Positioning Problem 13 13
Material Puncture/Hole 13 13
Increase in Pressure 11 11
Material Twisted/Bent 11 11
Device Appears to Trigger Rejection 10 10
Restricted Flow rate 9 9
Material Rupture 9 9
Patient-Device Incompatibility 9 9
Connection Problem 8 8
Free or Unrestricted Flow 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Reset Problem 7 7
Torn Material 7 7
Physical Resistance/Sticking 7 7
Excessive Heating 7 7
Device Markings/Labelling Problem 7 7
Malposition of Device 7 7
Failure to Advance 7 7
Improper or Incorrect Procedure or Method 7 7
Component Missing 7 7
Product Quality Problem 7 7
Misassembled 7 7
Kinked 7 7
No Device Output 7 7
Incorrect Measurement 6 6
Difficult to Remove 6 6
Device Or Device Fragments Location Unknown 6 6
Failure to Auto Stop 6 6
Unintended Movement 6 6
Therapeutic or Diagnostic Output Failure 6 6
Material Deformation 6 6
No Apparent Adverse Event 5 5
Separation Failure 5 5
Device Inoperable 5 5
Nonstandard Device 5 5
Hole In Material 5 5
Material Discolored 5 5
Flushing Problem 4 4
Retraction Problem 4 4
Failure to Prime 4 4
Self-Activation or Keying 4 4
Decrease in Pressure 4 4
Device Slipped 4 4
Physical Resistance 4 4
Device Displays Incorrect Message 4 4
Device Damaged Prior to Use 4 4
Application Program Problem 4 4
Communication or Transmission Problem 4 4
Material Protrusion/Extrusion 4 4
Inappropriate or Unexpected Reset 4 4
Device Fell 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1391 1391
Hydrocephalus 1151 1151
No Information 611 611
Failure of Implant 596 596
Injury 531 531
Unspecified Infection 401 401
Headache 369 370
No Clinical Signs, Symptoms or Conditions 326 326
Therapeutic Response, Decreased 309 309
Patient Problem/Medical Problem 178 178
No Consequences Or Impact To Patient 168 168
Therapeutic Effects, Unexpected 162 162
Cerebrospinal Fluid Leakage 160 160
Vomiting 134 134
Ambulation Difficulties 100 100
No Code Available 95 95
Insufficient Information 76 76
Cerebral Ventriculomeglia 76 76
Pain 72 73
Nausea 70 71
Hematoma 69 69
Neurological Deficit/Dysfunction 64 64
Dizziness 61 61
Complaint, Ill-Defined 60 60
Cognitive Changes 59 59
Fever 54 54
Death 45 45
Device Embedded In Tissue or Plaque 44 44
Coma 43 43
Intracranial Hemorrhage 41 41
Fatigue 40 41
Bacterial Infection 39 39
Visual Impairment 35 35
Lethargy 35 35
Seizures 34 34
Swelling 34 35
Loss of consciousness 29 29
Confusion/ Disorientation 28 28
Hemorrhage, Subdural 27 27
Discomfort 24 25
Foreign Body In Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Meningitis 22 22
Convulsion/Seizure 21 21
Seroma 20 20
Hemorrhage/Bleeding 20 20
Incontinence 19 19
Erosion 19 19
Cyst(s) 19 19
Staphylococcus Aureus 19 19
Malaise 19 19
Dysphasia 18 18
Blurred Vision 18 18
Hypersensitivity/Allergic reaction 17 17
Abdominal Pain 16 16
Inflammation 15 15
Muscle Weakness 14 14
Hemorrhage, Cerebral 13 13
Wound Dehiscence 13 13
No Patient Involvement 13 13
Irritability 12 12
Brain Injury 11 11
Vertigo 11 11
Tissue Damage 10 10
Loss of Vision 10 10
Weakness 10 10
Memory Loss/Impairment 10 10
Edema 10 10
Swelling/ Edema 10 10
Sleep Dysfunction 9 9
Dysphagia/ Odynophagia 9 9
Hemorrhage, Intraventricular 9 9
Paresis 9 9
Paralysis 8 8
Muscular Rigidity 8 8
Fall 8 8
Erythema 8 8
Abscess 8 8
Sepsis 8 8
Visual Disturbances 8 8
Tinnitus 8 8
Neck Stiffness 8 8
Post Operative Wound Infection 8 8
Fluid Discharge 8 8
Bowel Perforation 7 7
Obstruction/Occlusion 7 7
Fungal Infection 7 7
Urinary Tract Infection 7 7
Pneumonia 7 7
Ventricle, Abnormality Of 6 6
Reaction 6 6
Impaired Healing 6 6
Adhesion(s) 6 6
Stroke/CVA 6 6
High Blood Pressure/ Hypertension 6 6
Neck Pain 6 6
Hearing Impairment 5 5
Irritation 5 5
Cardiac Arrest 5 5
Host-Tissue Reaction 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Mar-01-2018
2 Integra LifeSciences Corp. II Dec-23-2020
3 Integra LifeSciences Corp. I May-20-2019
4 Medtronic Neurosurgery II Feb-12-2021
5 Medtronic Neurosurgery II Jan-15-2021
6 Medtronic Neurosurgery II Dec-28-2020
7 Medtronic Neurosurgery I Apr-07-2017
8 Medtronic Neurosurgery II Feb-02-2017
9 Natus Manufacturing Limited II Feb-22-2021
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