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 drug eluting permanent left ventricular (lv) pacemaker electrode
Definition Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Product CodeOJX
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
19 9 11 7 5 2

MDR Year MDR Reports MDR Events
2021 2869 2873
2022 2947 2962
2023 4468 4482
2024 3395 3399
2025 3420 3420
2026 834 834

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5332 5341
High Capture Threshold 3499 3503
Device Dislodged or Dislocated 2574 2580
Failure to Capture 2391 2393
Capturing Problem 1532 1537
High impedance 1491 1493
Impedance Problem 742 743
Positioning Problem 540 541
Low impedance 520 521
Activation, Positioning or Separation Problem 515 515
Unstable Capture Threshold 392 392
Fracture 386 386
Appropriate Term/Code Not Available 332 338
Break 320 321
Insufficient Information 294 296
Intermittent Capture 257 258
Pacing Problem 207 208
Material Integrity Problem 186 186
Over-Sensing 177 178
Ambient Noise Problem 171 171
Therapy Delivered to Incorrect Body Area 142 143
Pocket Stimulation 121 121
Signal Artifact/Noise 98 98
Device Sensing Problem 88 88
Therapeutic or Diagnostic Output Failure 84 84
Failure to Advance 78 78
Use of Device Problem 74 74
Electrical /Electronic Property Problem 65 65
Difficult to Remove 62 63
Inappropriate/Inadequate Shock/Stimulation 60 61
Stretched 50 50
Failure to Sense 41 41
Device Contamination with Body Fluid 41 41
Mechanical Problem 39 39
Defective Device 37 37
Output Problem 37 37
Separation Failure 32 32
No Pacing 31 31
Under-Sensing 31 32
Connection Problem 30 30
High Sensing Threshold 27 27
Material Twisted/Bent 24 24
Patient Device Interaction Problem 23 23
Device Handling Problem 22 22
Detachment of Device or Device Component 20 20
Improper or Incorrect Procedure or Method 20 20
Patient-Device Incompatibility 15 15
Accessory Incompatible 15 15
Product Quality Problem 14 14
Defective Component 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10266 10291
Unspecified Infection 3171 3172
Device Overstimulation of Tissue 945 947
Undesired Nerve Stimulation 846 846
Insufficient Information 831 833
Discomfort 355 356
Erythema 287 287
Bacterial Infection 249 250
Sepsis 231 231
Dyspnea 227 228
Erosion 226 226
Swelling/ Edema 217 218
Pocket Erosion 211 211
Purulent Discharge 198 198
Pain 161 161
Fever 146 146
Wound Dehiscence 142 142
Endocarditis 139 139
Chest Pain 136 136
Syncope/Fainting 116 117
Dizziness 106 106
Arrhythmia 102 102
Pericardial Effusion 101 102
Failure of Implant 100 100
Heart Failure/Congestive Heart Failure 98 98
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 91 92
Drug Resistant Bacterial Infection 85 85
Twiddlers Syndrome 80 80
Fatigue 66 66
Hematoma 65 65
Obstruction/Occlusion 61 62
Fluid Discharge 60 60
Vascular Dissection 59 59
Twitching 54 54
Fall 53 53
Tachycardia 51 51
Thrombosis/Thrombus 49 50
Low Blood Pressure/ Hypotension 48 49
Bradycardia 46 46
Muscle Weakness 43 43
Septic Shock 42 42
Cardiac Arrest 40 41
Cardiac Perforation 40 40
Cardiac Tamponade 36 36
Asystole 33 33
Perforation 30 30
Atrial Fibrillation 28 28
Shock from Patient Lead(s) 28 28
Presyncope 27 27
Heart Block 26 29

-
-