• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
  SUBSTANTIALLY EQUIVALENT 4
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
  SUBSTANTIALLY EQUIVALENT 6
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
JOHNSON & JOHNSON PROFESSIONALS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 1087 1087
2017 1331 1331
2018 1478 1478
2019 1295 1295
2020 1206 1206
2021 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 701 701
Adverse Event Without Identified Device or Use Problem 554 554
Appropriate Term/Code Not Available 546 546
Break 524 524
Insufficient Information 478 478
Obstruction of Flow 468 468
Device Operates Differently Than Expected 437 437
Occlusion Within Device 330 330
Mechanical Problem 309 309
Programming Issue 234 234
Leak/Splash 229 229
Fluid Leak 214 214
No Flow 114 114
Valve, Flow 113 113
Partial Blockage 112 112
Device Dislodged or Dislocated 110 110
Mechanics Altered 107 107
Fracture 105 105
Disconnection 100 100
Device Operational Issue 97 97
Pressure Problem 91 91
Device Difficult to Program or Calibrate 90 90
Use of Device Problem 90 90
Excess Flow or Over-Infusion 86 86
Inaccurate Flow Rate 79 79
Crack 79 79
Mechanical Jam 76 76
Electrical /Electronic Property Problem 63 63
Improper Flow or Infusion 60 60
Complete Blockage 59 59
Migration or Expulsion of Device 58 58
Insufficient Flow or Under Infusion 57 57
Material Separation 50 50
Defective Device 42 42
Detachment of Device or Device Component 38 38
Migration 37 37
Material Integrity Problem 36 36
Valve(s) 30 30
Detachment Of Device Component 28 28
Blocked Connection 28 28
Material Fragmentation 26 26
Catheter 23 23
Output Problem 22 22
Device Misassembled During Manufacturing /Shipping 22 22
Activation, Positioning or SeparationProblem 20 20
Defective Component 19 19
Overheating of Device 18 18
Loose or Intermittent Connection 15 15
Material Split, Cut or Torn 15 15
Separation Problem 14 14
Overcorrection 14 14
Shunt 14 14
Torn Material 13 13
Positioning Problem 12 12
Connection Problem 12 12
Product Quality Problem 11 11
Material Puncture/Hole 10 10
Incorrect, Inadequate or Imprecise Resultor Readings 10 10
Increase in Pressure 10 10
Failure to Prime 10 10
Air Leak 10 10
Kinked 9 9
Restricted Flow rate 9 9
Difficult to Remove 9 9
Improper or Incorrect Procedure or Method 9 9
Device Inoperable 9 9
Patient-Device Incompatibility 9 9
Device Contamination with Chemical or Other Material 8 8
Free or Unrestricted Flow 8 8
Material Twisted/Bent 8 8
Reset Problem 8 8
Device Or Device Fragments Location Unknown 8 8
Hole In Material 8 8
Flushing Problem 8 8
Transducer 8 8
Valve, Pressure Limit 8 8
Tube 7 7
Component Missing 7 7
Misassembled 7 7
Material Rupture 7 7
Device Appears to Trigger Rejection 7 7
Device Component Or Accessory 7 7
Device Markings/Labelling Problem 7 7
Failure to Auto Stop 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Deformation 6 6
Therapeutic or Diagnostic Output Failure 6 6
Tip 6 6
Device Slipped 6 6
Device Displays Incorrect Message 5 5
Malposition of Device 5 5
Failure to Advance 5 5
Separation Failure 5 5
Microbial Contamination of Device 5 5
Decrease in Pressure 5 5
Self-Activation or Keying 5 5
Nonstandard Device 5 5
Wire 5 5
Label 5 5
Material Discolored 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1604 1604
No Information 1052 1052
Hydrocephalus 599 599
Injury 508 508
Therapeutic Response, Decreased 472 472
Failure of Implant 451 451
Unspecified Infection 433 433
Headache 375 375
No Consequences Or Impact To Patient 180 180
Patient Problem/Medical Problem 178 178
Therapeutic Effects, Unexpected 162 162
Cerebrospinal Fluid Leakage 151 151
Vomiting 148 148
No Code Available 119 119
No Clinical Signs, Symptoms or Conditions 108 108
Ambulation Difficulties 82 82
Pain 71 71
Complaint, Ill-Defined 67 67
Neurological Deficit/Dysfunction 64 64
Hematoma 62 62
Fever 62 62
Nausea 61 61
Dizziness 60 60
Coma 59 59
Device Embedded In Tissue or Plaque 52 52
Death 49 49
Cognitive Changes 49 49
Swelling 38 38
Seizures 35 35
Fatigue 33 33
Lethargy 32 32
Loss of consciousness 29 29
Hemorrhage, Subdural 29 29
Visual Impairment 28 28
Confusion/ Disorientation 28 28
Discomfort 26 26
Bacterial Infection 26 26
Cerebral Ventriculomeglia 22 22
Meningitis 21 21
No Patient Involvement 19 19
Malaise 19 19
Staphylococcus Aureus 19 19
Foreign Body In Patient 18 18
Incontinence 18 18
Hemorrhage/Bleeding 17 17
Dysphasia 17 17
Erosion 17 17
Intracranial Hemorrhage 17 17
Seroma 16 16
Inflammation 15 15
Cyst(s) 15 15
Blurred Vision 14 14
Hemorrhage, Cerebral 13 13
Hypersensitivity/Allergic reaction 12 12
Abdominal Pain 12 12
Edema 11 11
Tissue Damage 11 11
Wound Dehiscence 11 11
Abscess 10 10
Hemorrhage, Intraventricular 10 10
Muscle Weakness 10 10
Insufficient Information 10 10
Brain Injury 10 10
Weakness 9 9
Reaction 9 9
Visual Disturbances 9 9
Vertigo 8 8
Fall 8 8
Memory Loss/Impairment 8 8
Paresis 8 8
High Blood Pressure/ Hypertension 8 8
Dysphagia/ Odynophagia 8 8
Fluid Discharge 8 8
Loss of Vision 8 8
Muscular Rigidity 8 8
Irritability 7 7
Neck Stiffness 7 7
Sleep Dysfunction 7 7
Fungal Infection 7 7
Neck Pain 6 6
Sepsis 6 6
Erythema 6 6
Host-Tissue Reaction 6 6
Irritation 6 6
Ventricle, Abnormality Of 6 6
Paralysis 6 6
Cardiac Arrest 5 5
Tinnitus 5 5
Swelling/ Edema 5 5
Tissue Breakdown 4 4
Tachycardia 4 4
Urinary Tract Infection 4 4
Disability 4 4
Breast Neoplasm 4 4
Stroke/CVA 4 4
Infarction, Cerebral 4 4
Facial Nerve Paralysis 4 4
Foreign Body Reaction 4 4
Low Blood Pressure/ Hypotension 4 4
Hearing Impairment 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
-
-