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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
Regulation Description Intracranial pressure monitoring device.
Product CodeGWM
Regulation Number 882.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.
  SUBSTANTIALLY EQUIVALENT 1
BRAINCARE DESENVOLVIMENTO E INOVAÇÃO TECNOLÓGICA S.A.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 268 268
2021 211 211
2022 424 424
2023 746 746
2024 642 642
2025 179 179

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 826 826
Break 334 334
Fracture 297 297
Disconnection 291 291
Incorrect, Inadequate or Imprecise Result or Readings 272 272
Output Problem 149 149
Electrical /Electronic Property Problem 67 67
Incorrect Measurement 64 64
Infusion or Flow Problem 62 62
Insufficient Information 45 45
Display or Visual Feedback Problem 38 38
Complete Blockage 36 36
Failure to Read Input Signal 35 35
Device Dislodged or Dislocated 35 35
No Device Output 34 34
Leak/Splash 31 31
Loose or Intermittent Connection 31 31
Adverse Event Without Identified Device or Use Problem 31 31
Failure to Zero 31 31
Connection Problem 28 28
Low Readings 27 27
Device Sensing Problem 22 22
High Readings 22 22
Unable to Obtain Readings 15 15
Appropriate Term/Code Not Available 12 12
Signal Artifact/Noise 12 12
Erratic Results 11 11
Device Displays Incorrect Message 11 11
Mechanical Problem 10 10
Device-Device Incompatibility 10 10
Image Display Error/Artifact 9 9
Loss of or Failure to Bond 9 9
Pressure Problem 8 8
Material Split, Cut or Torn 7 7
Mechanical Jam 7 7
Use of Device Problem 7 7
Unexpected Shutdown 6 6
Audible Prompt/Feedback Problem 6 6
Material Integrity Problem 6 6
Unstable 5 5
Crack 5 5
Detachment of Device or Device Component 4 4
Obstruction of Flow 4 4
Stretched 4 4
Communication or Transmission Problem 4 4
Material Fragmentation 4 4
Migration 3 3
Power Problem 3 3
Device Difficult to Program or Calibrate 3 3
Battery Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1751 1751
Insufficient Information 233 233
No Known Impact Or Consequence To Patient 165 165
Cerebrospinal Fluid Leakage 69 69
Injury 52 52
Failure of Implant 39 39
No Consequences Or Impact To Patient 36 36
Unspecified Infection 30 30
Unspecified Tissue Injury 21 21
Bacterial Infection 15 15
Headache 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Foreign Body In Patient 9 9
Fever 9 9
Device Embedded In Tissue or Plaque 8 8
Hematoma 8 8
Intracranial Hemorrhage 7 7
Not Applicable 4 4
Hydrocephalus 3 3
Coma 3 3
Vomiting 3 3
Hemorrhage/Bleeding 3 3
Malaise 3 3
Ambulation Difficulties 3 3
Death 3 3
Cerebral Edema 3 3
Unspecified Nervous System Problem 2 2
Muscle Weakness 2 2
Meningitis 2 2
Convulsion/Seizure 2 2
Visual Disturbances 2 2
No Code Available 2 2
Brain Injury 2 2
No Patient Involvement 2 2
Swelling/ Edema 2 2
Hemorrhage, Subarachnoid 1 1
Loss of consciousness 1 1
Irritability 1 1
Respiratory Failure 1 1
Cough 1 1
Missing Value Reason 1 1
Death, Intrauterine Fetal 1 1
Visual Impairment 1 1
Pain 1 1
Hernia 1 1
Urinary Retention 1 1
Exposure to Body Fluids 1 1
Burning Sensation 1 1
Confusion/ Disorientation 1 1
Post Operative Wound Infection 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 Medtronic Neurosurgery I Dec-19-2024
5 Smiths Medical ASD, Inc. II Oct-23-2024
6 Sophysa S.A. II May-15-2024
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