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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, monitoring, intracranial pressure
Product CodeGWM
Regulation Number 882.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.
  SUBSTANTIALLY EQUIVALENT 2
BRANCHPOINT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNERSPACE NEURO SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
RAUMEDIC AG
  SUBSTANTIALLY EQUIVALENT 1
SOPHYSA, SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 419 419
2017 439 439
2018 299 299
2019 260 260
2020 268 268
2021 211 211
2022 424 424
2023 746 746
2024 283 283

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 709 709
Incorrect, Inadequate or Imprecise Result or Readings 424 424
Break 354 354
Disconnection 316 316
Fracture 220 220
Output Problem 157 157
Device Operates Differently Than Expected 138 138
Device Displays Incorrect Message 93 93
Incorrect Measurement 93 93
Low Readings 92 92
Electrical /Electronic Property Problem 87 87
Unable to Obtain Readings 79 79
High Readings 78 78
Device Operational Issue 70 70
Leak/Splash 67 67
Adverse Event Without Identified Device or Use Problem 67 67
Use of Device Problem 63 63
Insufficient Information 57 57
Appropriate Term/Code Not Available 56 56
Failure to Zero 55 55
Infusion or Flow Problem 49 49
Connection Problem 46 46
Display or Visual Feedback Problem 46 46
Loose or Intermittent Connection 41 41
No Device Output 37 37
Failure to Read Input Signal 35 35
Device Sensing Problem 35 35
Device Dislodged or Dislocated 35 35
False Reading From Device Non-Compliance 29 29
Complete Blockage 26 26
Improper Device Output 21 21
Device Inoperable 17 17
No Display/Image 17 17
Pressure Problem 15 15
Device Difficult to Program or Calibrate 14 14
Failure to Power Up 14 14
Mechanical Problem 13 13
Detachment Of Device Component 13 13
Crack 13 13
Defective Device 13 13
Communication or Transmission Problem 13 13
Mechanical Jam 13 13
Material Integrity Problem 12 12
Device-Device Incompatibility 12 12
Defective Component 12 12
Bent 12 12
Erratic or Intermittent Display 12 12
Difficult to Insert 12 12
Occlusion Within Device 12 12
Failure to Sense 11 11
Improper or Incorrect Procedure or Method 11 11
Incorrect Or Inadequate Test Results 9 9
Erratic Results 9 9
Power Problem 8 8
Device Damaged Prior to Use 8 8
Battery Problem 8 8
Detachment of Device or Device Component 8 8
Loss of Power 8 8
Image Display Error/Artifact 8 8
Obstruction of Flow 7 7
Temperature Problem 7 7
Material Split, Cut or Torn 6 6
Failure to Calibrate 6 6
Product Quality Problem 6 6
Entrapment of Device 6 6
Material Fragmentation 6 6
Device Alarm System 6 6
Signal Artifact/Noise 5 5
Difficult to Remove 5 5
Decrease in Pressure 5 5
Failure to Select Signal 5 5
Overheating of Device 5 5
Device Or Device Fragments Location Unknown 5 5
Device Stops Intermittently 5 5
Malposition of Device 5 5
Calibration Problem 5 5
Activation, Positioning or Separation Problem 4 4
Invalid Sensing 4 4
High Test Results 4 4
Increase in Pressure 4 4
Component Incompatible 4 4
False Negative Result 4 4
Data Problem 4 4
Patient Data Problem 4 4
Device Handling Problem 4 4
Material Twisted/Bent 4 4
Positioning Problem 4 4
Protective Measures Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Noise, Audible 3 3
Migration 3 3
Material Discolored 3 3
Material Puncture/Hole 3 3
Failure to Reset 3 3
Device Difficult to Setup or Prepare 3 3
Device Issue 3 3
Failure to Advance 3 3
Component Missing 3 3
Self-Activation or Keying 3 3
Sticking 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1331 1331
No Known Impact Or Consequence To Patient 851 851
No Information 351 351
No Consequences Or Impact To Patient 302 302
Insufficient Information 152 152
Failure of Implant 75 75
Cerebrospinal Fluid Leakage 67 67
Injury 67 67
No Patient Involvement 63 63
Unspecified Infection 51 51
No Code Available 36 36
Device Embedded In Tissue or Plaque 25 25
Death 23 23
Unspecified Tissue Injury 21 21
Hematoma 19 19
Hemorrhage/Bleeding 17 17
Foreign Body In Patient 15 15
Headache 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Fever 11 11
Intracranial Hemorrhage 11 11
Patient Problem/Medical Problem 10 10
Complaint, Ill-Defined 9 9
Not Applicable 8 8
Bacterial Infection 8 8
Therapeutic Response, Decreased 7 7
Neurological Deficit/Dysfunction 7 7
Hydrocephalus 6 6
Coma 5 5
Brain Injury 4 4
Hernia 4 4
Ambulation Difficulties 4 4
Meningitis 3 3
Therapeutic Effects, Unexpected 3 3
Muscle Weakness 2 2
Ischemia 2 2
Test Result 2 2
Impaired Healing 2 2
Contusion 2 2
Tissue Damage 2 2
Hemorrhage, Cerebral 2 2
Convulsion/Seizure 2 2
Malaise 2 2
High Blood Pressure/ Hypertension 2 2
Perforation 2 2
Staphylococcus Aureus 2 2
Paralysis 2 2
Cardiac Arrest 2 2
Vomiting 2 2
Pain 2 2
Unspecified Nervous System Problem 2 2
Swelling/ Edema 2 2
Edema 2 2
Missing Value Reason 1 1
Hypoxia 1 1
Overdose 1 1
Headache, Lumbar Puncture 1 1
Necrosis 1 1
Intraocular Pressure Increased 1 1
Irritation 1 1
Low Oxygen Saturation 1 1
Fluid Discharge 1 1
Loss of consciousness 1 1
Fall 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Failure 1 1
Hemorrhage, Subarachnoid 1 1
Paraplegia 1 1
Dizziness 1 1
Head Injury 1 1
Shaking/Tremors 1 1
Cognitive Changes 1 1
Fungal Infection 1 1
Numbness 1 1
Air Embolism 1 1
Neck Stiffness 1 1
Swelling 1 1
Pregnancy 1 1
Paresis 1 1
Death, Intrauterine Fetal 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Urinary Retention 1 1
Breast Neoplasm 1 1
Vascular System (Circulation), Impaired 1 1
Visual Impairment 1 1
Confusion/ Disorientation 1 1
Twitching 1 1
Alteration In Body Temperature 1 1
Weakness 1 1
Seizures 1 1
Ventilator Dependent 1 1
Post Operative Wound Infection 1 1
High Oxygen Saturation 1 1
Burning Sensation 1 1
Cough 1 1
Hemorrhage, Intraventricular 1 1
Fatigue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. I Dec-14-2023
2 Integra LifeSciences Corp. II May-19-2023
3 Integra LifeSciences Corp. I Jul-22-2022
4 Integra LifeSciences Corp. II Oct-12-2019
5 Sophysa S.A. II May-15-2024
6 Spiegelberg Gmbh & Co. KG II Sep-26-2016
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