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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device permanent defibrillator electrodes
Definition Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.
Product CodeNVY
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
52 39 14 20 15 3

Device Problems
Over-Sensing 6528
Adverse Event Without Identified Device or Use Problem 6508
High impedance 5124
Device Dislodged or Dislocated 3710
Signal Artifact 3135
High Capture Threshold 3099
Inappropriate Shock 2922
Failure to Capture 2352
Break 1876
Ambient Noise Problem 1859
Fracture 1559
Low impedance 1485
Insulation 1316
Device Sensing Problem 1251
Capturing Problem 970
Impedance Problem 907
Under-Sensing 622
Decreased Sensitivity 527
Pacing Problem 490
Material Integrity Problem 477
Low Sensing Threshold 324
Appropriate Term/Code Not Available 302
Device Operates Differently Than Expected 271
Positioning Failure 245
Intermittent Capture 208
Retraction Problem 202
Human-Device Interface Problem 194
Failure to Sense 191
Defibrillation Problem 161
Helifix Coil 141
Insufficient Information 134
Defective Device 133
Difficult to Insert 120
Activation, Positioning or Separation Problem 116
Unstable Capture Threshold 108
Positioning Problem 104
Pocket Stimulation 98
Connection Problem 98
Failure to Convert Rhythm 93
Difficult to Remove 87
Mechanical Problem 74
Failure to Deliver Shock 73
Failure to Select Signal 63
High Sensing Threshold 60
Stylet 56
No Pacing 54
Migration or Expulsion of Device 53
Difficult To Position 52
Material Twisted / Bent 43
Device Abrasion From Instrument Or Another Object 39
Output Problem 36
Naturally Worn 35
Patient-Device Incompatibility 35
Electrical /Electronic Property Problem 34
Nonstandard device 33
Electromagnetic Interference 31
Sensing Intermittently 29
Incorrect Interpretation of signal 29
Bent 25
Device Contamination With Biological Material 24
Screw 24
Loose or Intermittent Connection 24
Kinked 23
Fitting Problem 21
Unexpected Therapeutic Results 20
Use of Device Problem 20
Therapeutic or Diagnostic Output Failure 17
Lead 17
Device Displays Incorrect Message 16
Device Damaged by Another Device 16
Material Deformation 14
Migration 14
Loss of Threshold 13
Electrical Lead 13
Separation Failure 12
Stretched 11
Failure to Advance 11
Energy Output Problem 10
Device Contamination with Chemical or Other Material 9
Pacing Inadequately 9
Collapse 9
Defective Component 8
Aborted Charge 8
No Apparent Adverse Event 8
Failure to Interrogate 8
Contamination / decontamination Problem 8
Failure to Disconnect 8
Device Alarm System 7
Pacing Intermittently 7
Device Contamination with Body Fluid 7
Difficult to Fold or Unfold 7
Difficult or Delayed Positioning 7
Cut In Material 6
Premature Activation 6
Material Separation 6
Deformation Due to Compressive Stress 5
Accessory Incompatible 5
Connector Pin 5
Therapy Delivered to Incorrect Body Area 5
Detachment of Device or device Component 5
Total Device Problems 51374


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