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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
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 264 264

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2190 2190
Mechanical Problem 946 946
Insufficient Information 620 620
Obstruction of Flow 574 574
Adverse Event Without Identified Device or Use Problem 516 516
Break 470 470
Fluid/Blood Leak 313 313
Appropriate Term/Code Not Available 228 228
Fracture 210 210
Complete Blockage 203 203
Mechanics Altered 121 121
Pressure Problem 113 113
Output Problem 104 104
Device Difficult to Program or Calibrate 86 86
Leak/Splash 83 83
Crack 76 76
Disconnection 66 66
Electrical /Electronic Property Problem 65 65
Migration 65 65
Mechanical Jam 57 57
Material Integrity Problem 47 47
Material Split, Cut or Torn 45 45
Device Dislodged or Dislocated 41 41
No Flow 40 40
Detachment of Device or Device Component 33 33
Insufficient Flow or Under Infusion 29 29
Defective Device 28 28
Separation Problem 27 27
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Material Separation 25 25
Excess Flow or Over-Infusion 25 25
Improper Flow or Infusion 24 24
Device Misassembled During Manufacturing /Shipping 23 23
Use of Device Problem 22 22
Material Fragmentation 21 21
Positioning Problem 20 20
Activation, Positioning or Separation Problem 20 20
Loose or Intermittent Connection 19 19
No Device Output 17 17
Defective Component 17 17
Migration or Expulsion of Device 15 15
Difficult to Remove 12 12
Material Twisted/Bent 11 11
Therapeutic or Diagnostic Output Failure 11 11
Increase in Pressure 11 11
Unintended Movement 11 11
Material Puncture/Hole 10 10
Device Appears to Trigger Rejection 10 10
Physical Resistance/Sticking 9 9
Excessive Heating 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Overheating of Device 8 8
Product Quality Problem 8 8
Retraction Problem 8 8
Microbial Contamination of Device 7 7
Malposition of Device 7 7
Partial Blockage 7 7
Patient Device Interaction Problem 7 7
Material Deformation 6 6
Reset Problem 6 6
Entrapment of Device 6 6
Free or Unrestricted Flow 6 6
Component Missing 6 6
No Apparent Adverse Event 6 6
Inappropriate or Unexpected Reset 6 6
Contamination 6 6
Failure to Advance 6 6
Gas/Air Leak 6 7
Patient-Device Incompatibility 5 5
Failure to Read Input Signal 5 5
Device Fell 5 5
Connection Problem 5 5
Material Frayed 5 5
Device Markings/Labelling Problem 5 5
Device Unsafe to Use in Environment 5 5
Material Rupture 5 5
Decrease in Pressure 5 5
Material Protrusion/Extrusion 4 4
Audible Prompt/Feedback Problem 4 4
Packaging Problem 4 4
Loss of or Failure to Bond 4 4
Communication or Transmission Problem 4 4
Calcified 4 4
Expiration Date Error 3 3
Program or Algorithm Execution Failure 3 3
Material Discolored 3 3
Unexpected Therapeutic Results 3 3
Incorrect Measurement 3 3
Delivered as Unsterile Product 3 3
Device Slipped 3 3
Nonstandard Device 3 3
Labelling, Instructions for Use or Training Problem 3 3
Noise, Audible 3 3
Unable to Obtain Readings 3 3
Difficult to Insert 3 3
Difficult to Advance 3 3
Application Program Problem 3 3
Fitting Problem 3 3
Reflux within Device 2 2
Positioning Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2022 2022
No Clinical Signs, Symptoms or Conditions 959 959
No Known Impact Or Consequence To Patient 555 555
Failure of Implant 554 554
Injury 513 513
Insufficient Information 422 422
Headache 338 338
Unspecified Infection 254 254
Patient Problem/Medical Problem 173 173
Cerebral Ventriculomeglia 169 169
Cerebrospinal Fluid Leakage 167 167
Unspecified Tissue Injury 125 125
No Consequences Or Impact To Patient 108 108
Vomiting 106 106
Therapeutic Effects, Unexpected 103 103
Ambulation Difficulties 86 86
Hematoma 79 79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
Bacterial Infection 63 63
Intracranial Hemorrhage 53 53
Fever 52 52
Pain 51 51
Nausea 48 48
Cognitive Changes 46 46
Confusion/ Disorientation 45 45
Dizziness 45 45
Convulsion/Seizure 44 44
Foreign Body In Patient 38 38
Coma 37 37
Hemorrhage/Bleeding 36 36
Visual Impairment 34 34
Swelling/ Edema 30 30
Device Embedded In Tissue or Plaque 29 29
Fatigue 29 29
Meningitis 24 24
Death 23 23
No Code Available 23 23
Lethargy 22 22
Loss of consciousness 20 20
Brain Injury 19 19
Blurred Vision 18 18
Complaint, Ill-Defined 18 18
Seroma 18 18
Swelling 17 18
Hypersensitivity/Allergic reaction 17 17
Neurological Deficit/Dysfunction 16 16
Dysphasia 15 15
Hemorrhage, Subdural 15 15
Cyst(s) 15 15
Abdominal Pain 15 15
Irritability 14 14
Discomfort 13 13
High Blood Pressure/ Hypertension 13 13
Memory Loss/Impairment 13 13
Impaired Healing 13 13
No Information 13 13
Unspecified Nervous System Problem 13 13
Paralysis 12 12
Wound Dehiscence 12 12
Inflammation 11 11
Post Operative Wound Infection 11 11
Seizures 11 11
Loss of Vision 11 11
Urinary Tract Infection 10 10
Pneumonia 10 10
Malaise 10 10
Incontinence 10 10
Hearing Impairment 10 10
Laceration(s) 9 9
Arrhythmia 9 9
Erythema 9 9
Respiratory Failure 9 9
Emotional Changes 8 8
Adhesion(s) 8 8
Abscess 7 7
Erosion 7 7
Stroke/CVA 7 7
Paresis 7 7
Therapeutic Response, Decreased 7 7
Obstruction/Occlusion 7 7
Visual Disturbances 7 7
Sleep Dysfunction 7 7
Cerebral Edema 7 7
Fluid Discharge 7 7
Thrombosis/Thrombus 7 7
Bowel Perforation 6 6
Tinnitus 6 6
Loss of Range of Motion 6 6
Rash 6 6
Depression 6 6
Muscle Weakness 6 6
Diarrhea 6 6
Fall 6 6
Dysphagia/ Odynophagia 5 5
Head Injury 5 5
Fistula 5 5
Urinary Frequency 5 5
Local Reaction 5 5
Weakness 5 5
Balance Problems 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Dec-23-2020
2 Integra LifeSciences Corp. I May-20-2019
3 Medtronic Neurosurgery II Aug-17-2023
4 Medtronic Neurosurgery II Feb-12-2021
5 Medtronic Neurosurgery II Jan-15-2021
6 Medtronic Neurosurgery II Dec-28-2020
7 Natus Manufacturing Limited II Feb-22-2021
8 Natus Medical Incorporated II Jan-04-2024
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