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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
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 295 295
2019 260 260
2020 268 268
2021 211 211
2022 425 425

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 352 352
Fluid/Blood Leak 154 154
Break 144 144
Output Problem 114 114
Fracture 91 91
Electrical /Electronic Property Problem 60 60
Incorrect Measurement 51 51
Unable to Obtain Readings 46 46
Adverse Event Without Identified Device or Use Problem 37 37
Disconnection 34 34
Insufficient Information 33 33
Appropriate Term/Code Not Available 30 30
Infusion or Flow Problem 28 28
Low Readings 27 27
Failure to Zero 25 25
Connection Problem 25 25
High Readings 21 21
No Device Output 20 20
Leak/Splash 18 18
Use of Device Problem 17 17
Device Dislodged or Dislocated 16 16
Display or Visual Feedback Problem 16 16
Loose or Intermittent Connection 16 16
Failure to Read Input Signal 16 16
Device Sensing Problem 14 14
False Reading From Device Non-Compliance 11 11
Device Displays Incorrect Message 11 11
Device Difficult to Program or Calibrate 10 10
Complete Blockage 10 10
Device Operational Issue 9 9
Detachment of Device or Device Component 8 8
Mechanical Problem 8 8
Crack 7 7
Defective Device 7 7
Communication or Transmission Problem 7 7
Device-Device Incompatibility 7 7
Material Integrity Problem 7 7
Pressure Problem 6 6
Image Display Error/Artifact 6 6
Device Operates Differently Than Expected 6 6
Material Split, Cut or Torn 5 5
No Display/Image 4 4
Device Damaged Prior to Use 4 4
Difficult to Remove 4 4
False Negative Result 4 4
Power Problem 4 4
Defective Component 3 3
Material Fragmentation 3 3
Failure to Sense 3 3
Invalid Sensing 3 3
Increase in Pressure 3 3
Entrapment of Device 3 3
Overheating of Device 3 3
Obstruction of Flow 3 3
Therapeutic or Diagnostic Output Failure 3 3
Deformation Due to Compressive Stress 3 3
Calibration Problem 3 3
Activation, Positioning or Separation Problem 3 3
Erratic Results 2 2
Shipping Damage or Problem 2 2
Device Difficult to Setup or Prepare 2 2
Difficult to Insert 2 2
Device Alarm System 2 2
Failure to Reset 2 2
Malposition of Device 2 2
Audible Prompt/Feedback Problem 2 2
Device Issue 2 2
Failure to Power Up 2 2
Patient-Device Incompatibility 2 2
Material Twisted/Bent 2 2
Mechanical Jam 2 2
Protective Measures Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Improper Device Output 2 2
Device Stops Intermittently 2 2
Contamination 2 2
Battery Problem 2 2
Migration 2 2
Excessive Heating 1 1
Detachment Of Device Component 1 1
Peeled/Delaminated 1 1
Device Inoperable 1 1
Unstable 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Low Test Results 1 1
Device Handling Problem 1 1
Installation-Related Problem 1 1
Material Protrusion/Extrusion 1 1
Sparking 1 1
Material Separation 1 1
Migration or Expulsion of Device 1 1
Loss of Power 1 1
Component Incompatible 1 1
Non Reproducible Results 1 1
Premature Separation 1 1
Device Markings/Labelling Problem 1 1
Difficult to Advance 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 465 465
No Known Impact Or Consequence To Patient 449 449
No Consequences Or Impact To Patient 150 150
Failure of Implant 75 75
Injury 66 66
Cerebrospinal Fluid Leakage 51 51
Insufficient Information 46 46
No Information 46 46
Unspecified Infection 23 23
Device Embedded In Tissue or Plaque 13 13
Death 12 12
Hematoma 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Hemorrhage/Bleeding 9 9
No Code Available 9 9
Headache 9 9
Patient Problem/Medical Problem 8 8
Unspecified Tissue Injury 8 8
Neurological Deficit/Dysfunction 7 7
Fever 7 7
Intracranial Hemorrhage 6 6
Foreign Body In Patient 6 6
Hydrocephalus 5 5
No Patient Involvement 5 5
Not Applicable 4 4
Bacterial Infection 4 4
Brain Injury 3 3
Hernia 3 3
Therapeutic Effects, Unexpected 3 3
Coma 3 3
Ischemia 2 2
Test Result 2 2
Complaint, Ill-Defined 2 2
Impaired Healing 2 2
Vomiting 2 2
Pain 2 2
Paralysis 2 2
Contusion 2 2
Edema 2 2
Death, Intrauterine Fetal 1 1
Necrosis 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Visual Impairment 1 1
Twitching 1 1
Meningitis 1 1
Breast Neoplasm 1 1
Vascular System (Circulation), Impaired 1 1
Missing Value Reason 1 1
Unspecified Nervous System Problem 1 1
Hemorrhage, Cerebral 1 1
Swelling 1 1
Neck Stiffness 1 1
Respiratory Failure 1 1
Fluid Discharge 1 1
Convulsion/Seizure 1 1
Seizures 1 1
Weakness 1 1
Burning Sensation 1 1
Hemorrhage, Subarachnoid 1 1
Ventilator Dependent 1 1
Post Operative Wound Infection 1 1
High Oxygen Saturation 1 1
Shaking/Tremors 1 1
Cardiac Arrest 1 1
Muscle Weakness 1 1
Perforation 1 1
Staphylococcus Aureus 1 1
Hemorrhage, Intraventricular 1 1
Fatigue 1 1
Ambulation Difficulties 1 1
Cognitive Changes 1 1
Cough 1 1
Air Embolism 1 1
Numbness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. I Jul-22-2022
2 Integra LifeSciences Corp. II Oct-12-2019
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