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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 3
ARKIS BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
BTG INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
IRRAS INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROSURGERY
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 1090 1090
2017 1333 1333
2018 1482 1482
2019 1295 1295
2020 1206 1206
2021 872 872

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 988 988
Adverse Event Without Identified Device or Use Problem 626 626
Break 568 568
Appropriate Term/Code Not Available 557 557
Obstruction of Flow 536 536
Insufficient Information 514 514
Device Operates Differently Than Expected 437 437
Mechanical Problem 412 412
Occlusion Within Device 330 330
Fluid Leak 241 241
Programming Issue 234 234
Leak/Splash 234 234
Mechanics Altered 122 122
Fracture 122 122
No Flow 120 120
Device Dislodged or Dislocated 115 115
Partial Blockage 112 112
Disconnection 108 108
Pressure Problem 103 103
Device Difficult to Program or Calibrate 98 98
Device Operational Issue 97 97
Use of Device Problem 94 94
Excess Flow or Over-Infusion 91 91
Crack 83 83
Mechanical Jam 80 80
Inaccurate Flow Rate 79 79
Complete Blockage 73 73
Insufficient Flow or Under Infusion 65 65
Electrical /Electronic Property Problem 63 63
Improper Flow or Infusion 63 63
Output Problem 63 63
Migration or Expulsion of Device 59 59
Material Separation 52 52
Defective Device 46 46
Migration 46 46
Material Integrity Problem 41 41
Detachment of Device or Device Component 40 40
Blocked Connection 28 28
Detachment Of Device Component 28 28
Material Fragmentation 27 27
Device Misassembled During Manufacturing /Shipping 22 22
Material Split, Cut or Torn 21 21
Activation, Positioning or SeparationProblem 20 20
Defective Component 20 20
Overheating of Device 19 19
Separation Problem 17 17
Loose or Intermittent Connection 16 16
Incorrect, Inadequate or Imprecise Resultor Readings 15 15
Overcorrection 14 14
Torn Material 13 13
Product Quality Problem 13 13
Connection Problem 13 13
Positioning Problem 12 12
Material Puncture/Hole 12 12
Increase in Pressure 11 11
Difficult to Remove 10 10
Failure to Prime 10 10
Air Leak 10 10
Patient-Device Incompatibility 9 9
Device Inoperable 9 9
Improper or Incorrect Procedure or Method 9 9
Device Appears to Trigger Rejection 9 9
Restricted Flow rate 9 9
Kinked 9 9
Material Rupture 8 8
Device Contamination with Chemical or Other Material 8 8
Free or Unrestricted Flow 8 8
Reset Problem 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Device Or Device Fragments Location Unknown 8 8
No Device Output 8 8
Flushing Problem 8 8
Hole In Material 8 8
Material Twisted/Bent 8 8
Therapeutic or Diagnostic Output Failure 7 7
Component Missing 7 7
Device Markings/Labelling Problem 7 7
Unintended Movement 7 7
Misassembled 7 7
Device Displays Incorrect Message 6 6
Malposition of Device 6 6
Physical Resistance/Sticking 6 6
Material Deformation 6 6
Excessive Heating 6 6
Device Slipped 6 6
Incorrect Measurement 6 6
Packaging Problem 6 6
Failure to Auto Stop 6 6
No Apparent Adverse Event 5 5
Nonstandard Device 5 5
Microbial Contamination of Device 5 5
Separation Failure 5 5
Failure to Advance 5 5
Decrease in Pressure 5 5
Self-Activation or Keying 5 5
Material Discolored 5 5
Delivered as Unsterile Product 4 4
Device Damaged Prior to Use 4 4
Improper Device Output 4 4
Inappropriate or Unexpected Reset 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1613 1613
No Information 1052 1052
Hydrocephalus 861 861
Failure of Implant 548 548
Injury 533 533
Therapeutic Response, Decreased 472 472
Unspecified Infection 457 457
Headache 409 410
No Clinical Signs, Symptoms or Conditions 245 245
No Consequences Or Impact To Patient 186 186
Patient Problem/Medical Problem 178 178
Therapeutic Effects, Unexpected 162 162
Cerebrospinal Fluid Leakage 160 160
Vomiting 157 157
No Code Available 119 119
Ambulation Difficulties 91 91
Pain 77 78
Hematoma 72 72
Fever 68 68
Complaint, Ill-Defined 67 67
Dizziness 65 65
Nausea 64 65
Neurological Deficit/Dysfunction 64 64
Coma 63 63
Insufficient Information 61 61
Cerebral Ventriculomeglia 55 55
Device Embedded In Tissue or Plaque 54 54
Cognitive Changes 53 53
Death 49 49
Swelling 38 39
Fatigue 36 37
Seizures 35 35
Visual Impairment 32 32
Bacterial Infection 32 32
Confusion/ Disorientation 32 32
Lethargy 32 32
Intracranial Hemorrhage 31 31
Loss of consciousness 31 31
Hemorrhage, Subdural 29 29
Discomfort 28 29
Meningitis 24 24
Foreign Body In Patient 23 23
No Patient Involvement 19 19
Seroma 19 19
Hemorrhage/Bleeding 19 19
Malaise 19 19
Staphylococcus Aureus 19 19
Erosion 19 19
Cyst(s) 18 18
Incontinence 18 18
Dysphasia 17 17
Hypersensitivity/Allergic reaction 15 15
Inflammation 15 15
Blurred Vision 14 14
Abdominal Pain 13 13
Hemorrhage, Cerebral 13 13
Wound Dehiscence 12 12
Muscle Weakness 12 12
Convulsion/Seizure 12 12
Irritability 12 12
Tissue Damage 11 11
Edema 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Abscess 10 10
Hemorrhage, Intraventricular 10 10
Loss of Vision 10 10
Weakness 10 10
Brain Injury 10 10
Reaction 9 9
Swelling/ Edema 9 9
Dysphagia/ Odynophagia 9 9
Memory Loss/Impairment 9 9
Visual Disturbances 9 9
Vertigo 8 8
Fall 8 8
Paresis 8 8
Erythema 8 8
High Blood Pressure/ Hypertension 8 8
Fluid Discharge 8 8
Sleep Dysfunction 8 8
Neck Stiffness 8 8
Muscular Rigidity 8 8
Paralysis 7 7
Bowel Perforation 7 7
Fungal Infection 7 7
Neck Pain 6 6
Sepsis 6 6
Irritation 6 6
Host-Tissue Reaction 6 6
Stroke/CVA 6 6
Tinnitus 6 6
Ventricle, Abnormality Of 6 6
Obstruction/Occlusion 6 6
Post Operative Wound Infection 6 6
Impaired Healing 6 6
Urinary Tract Infection 5 5
Cardiac Arrest 5 5
Hearing Impairment 5 5
Low Blood Pressure/ Hypotension 4 4
Numbness 4 4

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 Integra LifeSciences Corp. II Sep-30-2016
5 Medtronic Neurosurgery II Feb-12-2021
6 Medtronic Neurosurgery II Jan-15-2021
7 Medtronic Neurosurgery II Dec-28-2020
8 Medtronic Neurosurgery I Apr-07-2017
9 Medtronic Neurosurgery II Feb-02-2017
10 Natus Manufacturing Limited II Feb-22-2021
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