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)
2019 2020 2021 2022 2023 2024
0 0 0 1 1 1

MDR Year MDR Reports MDR Events
2019 32 32
2020 18 18
2021 36 36
2022 44 44
2023 64 64
2024 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 86 86
High impedance 46 46
Insufficient Information 35 35
Battery Problem 24 24
Break 23 23
Failure to Deliver Energy 21 21
Malposition of Device 15 15
Communication or Transmission Problem 14 14
Low impedance 13 13
Charging Problem 12 12
Migration or Expulsion of Device 11 11
Impedance Problem 11 11
Failure to Power Up 9 9
Failure to Interrogate 8 8
Unintended Collision 6 6
Unstable 6 6
Energy Output Problem 6 6
Material Integrity Problem 6 6
Improper or Incorrect Procedure or Method 5 5
Display or Visual Feedback Problem 5 5
Premature Discharge of Battery 5 5
Connection Problem 5 5
Intermittent Continuity 5 5
Loss of Data 4 4
Delayed Charge Time 4 4
Application Program Problem 4 4
Patient Device Interaction Problem 4 4
Electromagnetic Compatibility Problem 4 4
Difficult to Open or Close 3 3
Positioning Problem 3 3
Overheating of Device 3 3
Appropriate Term/Code Not Available 3 3
Material Deformation 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Therapy Delivered to Incorrect Body Area 2 2
Electromagnetic Interference 2 2
Data Problem 2 2
Device Damaged by Another Device 2 2
Difficult to Remove 2 2
Therapeutic or Diagnostic Output Failure 2 2
Vibration 2 2
Material Twisted/Bent 1 1
Difficult to Insert 1 1
Degraded 1 1
Pocket Stimulation 1 1
Defective Component 1 1
Electro-Static Discharge 1 1
Corroded 1 1
Material Disintegration 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 113
Convulsion/Seizure 40 40
Insufficient Information 27 27
Unspecified Infection 23 23
No Known Impact Or Consequence To Patient 17 17
Cognitive Changes 16 16
Pain 14 14
Seizures 11 11
Headache 8 8
Fall 6 6
Discomfort 6 6
Depression 6 6
Shaking/Tremors 6 6
Memory Loss/Impairment 6 6
Dysphasia 5 5
Suicidal Ideation 5 5
Stroke/CVA 5 5
Emotional Changes 5 5
Therapeutic Effects, Unexpected 5 5
Sleep Dysfunction 4 4
Complaint, Ill-Defined 4 4
Fever 4 4
Intracranial Hemorrhage 4 4
Hematoma 4 4
Paresis 3 3
Muscular Rigidity 3 3
Anxiety 3 3
Burning Sensation 3 3
Incontinence 3 3
Therapeutic Response, Decreased 3 3
Confusion/ Disorientation 3 3
Dizziness 3 3
Meningitis 3 3
Erosion 3 3
Electric Shock 3 3
Hemorrhage/Bleeding 3 3
Ambulation Difficulties 3 3
Adhesion(s) 2 2
Neurological Deficit/Dysfunction 2 2
Irritability 2 2
Paresthesia 2 2
Swelling/ Edema 2 2
Paralysis 2 2
Nausea 2 2
Bacterial Infection 2 2
Fatigue 2 2
Undesired Nerve Stimulation 2 2
Loss of consciousness 2 2
Tingling 2 2
Numbness 2 2

-
-