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, electrical, implanted, for essential tremor
Definition Deep Brain Stimulation for the treatment of essential tremor
Product CodePJS
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 0 0 0 0 0

MDR Year MDR Reports MDR Events
2021 202 204
2022 294 299
2023 543 543
2024 492 492
2025 425 425
2026 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 391 391
Adverse Event Without Identified Device or Use Problem 362 364
Material Integrity Problem 341 341
Battery Problem 285 285
Failure to Deliver Energy 234 234
Charging Problem 233 234
Insufficient Information 226 228
Inappropriate/Inadequate Shock/Stimulation 194 194
Communication or Transmission Problem 190 190
High impedance 188 189
Failure to Interrogate 120 120
Energy Output Problem 109 109
Failure to Power Up 98 98
Improper or Incorrect Procedure or Method 84 84
Electromagnetic Compatibility Problem 71 71
Break 67 68
Impedance Problem 66 66
Low impedance 64 64
Migration or Expulsion of Device 56 56
Malposition of Device 55 55
Delayed Charge Time 48 48
Display or Visual Feedback Problem 43 43
Unintended Collision 40 40
Unexpected Therapeutic Results 39 39
Intermittent Continuity 37 37
No Device Output 32 32
Premature Discharge of Battery 31 31
Electromagnetic Interference 31 31
Therapeutic or Diagnostic Output Failure 30 30
Material Frayed 29 29
Patient Device Interaction Problem 28 28
Unstable 23 24
Overheating of Device 22 22
Therapy Delivered to Incorrect Body Area 21 21
Use of Device Problem 16 16
Loss of Data 12 12
Application Program Problem 10 10
Migration 10 10
Data Problem 10 10
Material Deformation 9 9
Vibration 8 8
Positioning Problem 7 8
Operating System Becomes Nonfunctional 7 7
Difficult to Open or Close 6 6
Audible Prompt/Feedback Problem 6 6
Noise, Audible 6 6
Corroded 5 5
Human-Device Interface Problem 5 5
Difficult to Remove 5 5
Device Difficult to Program or Calibrate 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1177 1179
Shaking/Tremors 372 372
Insufficient Information 268 270
Electric Shock 190 190
Unspecified Infection 110 112
Ambulation Difficulties 76 77
Pain 71 72
Dysphasia 70 70
Paresthesia 62 62
Discomfort 45 45
Erosion 44 44
Fall 33 33
Bacterial Infection 28 28
Undesired Nerve Stimulation 27 27
Convulsion/Seizure 26 27
Swelling/ Edema 24 24
Erythema 24 24
Numbness 23 23
Cognitive Changes 22 23
Dizziness 22 22
Intracranial Hemorrhage 20 20
Stroke/CVA 19 19
Headache 18 18
Purulent Discharge 18 18
Burning Sensation 16 16
Device Overstimulation of Tissue 15 15
Wound Dehiscence 14 14
Muscle Weakness 12 12
Scar Tissue 11 11
Cramp(s) /Muscle Spasm(s) 11 11
Muscular Rigidity 11 11
Fluid Discharge 10 10
Pocket Erosion 10 10
Hemorrhage/Bleeding 9 9
Memory Loss/Impairment 9 10
Skin Erosion 8 8
Visual Impairment 8 8
Confusion/ Disorientation 8 9
Hematoma 7 8
Loss of consciousness 7 7
Unspecified Tissue Injury 7 8
Paresis 6 6
Transient Ischemic Attack 6 6
Malaise 6 6
Nausea 6 6
Speech Disorder 6 6
Neck Stiffness 5 5
Inflammation 5 5
Bone Fracture(s) 5 5
Fatigue 5 6

-
-