Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 stimulator, thalamic, epilepsy, implanted
Product CodeMBX
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
1 0 0 0 1 1

MDR Year MDR Reports MDR Events
2018 8 8
2019 32 32
2020 17 17
2021 36 36
2022 44 44
2023 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 62 62
Insufficient Information 22 22
High impedance 19 19
Battery Problem 16 16
Break 13 13
Low impedance 12 12
Malposition of Device 9 9
Failure to Deliver Energy 9 9
Communication or Transmission Problem 8 8
Migration or Expulsion of Device 7 7
Unintended Collision 6 6
Energy Output Problem 5 5
Unstable 5 5
Improper or Incorrect Procedure or Method 5 5
Failure to Interrogate 5 5
Charging Problem 5 5
Impedance Problem 4 4
Intermittent Continuity 4 4
Premature Discharge of Battery 4 4
Delayed Charge Time 4 4
Appropriate Term/Code Not Available 3 3
Positioning Problem 3 3
Loss of Data 3 3
Application Program Problem 3 3
Device Damaged by Another Device 2 2
Difficult to Open or Close 2 2
Electromagnetic Compatibility Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Deformation 2 2
Electromagnetic Interference 2 2
Vibration 2 2
Patient Device Interaction Problem 2 2
Electro-Static Discharge 1 1
Overheating of Device 1 1
Peeled/Delaminated 1 1
Pocket Stimulation 1 1
Therapy Delivered to Incorrect Body Area 1 1
Display or Visual Feedback Problem 1 1
Difficult to Insert 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Device Contamination with Chemical or Other Material 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
No Known Impact Or Consequence To Patient 20 20
Insufficient Information 18 18
Convulsion/Seizure 17 17
Unspecified Infection 16 16
Seizures 14 14
Cognitive Changes 13 13
Pain 7 7
Fall 6 6
Shaking/Tremors 6 6
Complaint, Ill-Defined 6 6
Depression 5 5
Therapeutic Effects, Unexpected 5 5
Stroke/CVA 5 5
Emotional Changes 4 4
Fever 4 4
Headache 4 4
Hematoma 3 3
Erosion 3 3
Paresis 3 3
Memory Loss/Impairment 3 3
Muscular Rigidity 3 3
Intracranial Hemorrhage 3 3
Dysphasia 3 3
Meningitis 3 3
Therapeutic Response, Decreased 3 3
Sleep Dysfunction 3 3
Irritability 3 3
Ambulation Difficulties 2 2
Test Result 2 2
Anxiety 2 2
Discomfort 2 2
Tingling 2 2
Visual Impairment 2 2
Vomiting 2 2
Pocket Erosion 2 2
Neurological Deficit/Dysfunction 2 2
Scar Tissue 2 2
Nausea 2 2
Paralysis 2 2
Adhesion(s) 2 2
Bacterial Infection 2 2
Erythema 2 2
Fatigue 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Loss of consciousness 2 2
Paresthesia 1 1
Unspecified Tissue Injury 1 1
Hemorrhage/Bleeding 1 1
Head Injury 1 1
Wound Dehiscence 1 1
Arrhythmia 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Infarction, Cerebral 1 1
Chest Pain 1 1
Pneumonia 1 1
Undesired Nerve Stimulation 1 1
Muscle Weakness 1 1
Hemorrhage, Subdural 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Inflammation 1 1
Irritation 1 1
Laceration(s) 1 1
Pulmonary Edema 1 1
Twiddlers Syndrome 1 1
Vertigo 1 1
Sepsis 1 1
Weakness 1 1
Burning Sensation 1 1
Loss of Vision 1 1
Twitching 1 1
Dizziness 1 1
Brain Injury 1 1
Fracture, Arm 1 1
Malaise 1 1
Numbness 1 1
Impaired Healing 1 1
Confusion/ Disorientation 1 1
Weight Changes 1 1
Neck Stiffness 1 1
Post Operative Wound Infection 1 1

-
-