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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)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
12 27 30 82 89 92 96 86 52 29

Device Problems
High impedance 3288
Oversensing 3199
Dislodged or dislocated 1975
Inappropriate shock 1793
Failure to capture 1565
Device sensing issue 1545
No code available 1436
Low impedance 1302
No Known Device Problem 1186
High capture threshold 1096
Fracture 1023
Break 1000
No Information 907
Failure to pace or properly pace 579
Low sensing threshold 494
Material integrity issue 471
Ambient noise issue 433
Impedance issue 309
Undersensing 250
Device operates differently than expected 248
Connection issue 243
Capturing issue 216
Decreased sensitivity 156
Failure to shock or properly shock 134
High sensing threshold 126
Artifact 111
Failure to sense 94
Human-Device Interface Issue 83
Device displays error message 79
Device Issue 73
Loose or intermittent connection 70
Failure to deploy 68
Noise 68
Pocket stimulation 68
Difficult to position 65
Aborted charge 58
Intermittent capture 57
Failure to convert rhythm 55
Invalid sensing 54
Difficult to remove 47
Migration of device or device component 43
Fitting problem 40
Use of Device Issue 40
Retraction problem 36
Nonstandard device or device component 34
Difficult to insert 24
Deployment issue 21
Electrical issue 20
Disinfection or Sterilization Issue at User Location 19
Loss of threshold 18
Positioning Issue 18
Sensing intermittently 17
Mechanical issue 16
Device damaged prior to use 16
Device alarm system issue 14
Dislodged 11
Unstable capture threshold 11
Output issue 10
Device abrasion from instrument or another object 10
Short fill 10
No device output 10
Electro-magnetic interference (EMI) 9
Bent 8
Kinked 6
Device Contamination with biological material 6
Device or device component damaged by another device 5
Component(s), broken 5
Normal 5
Failure to interrogate 4
Difficult to deploy 4
Lead(s), fracture of 4
Malposition of device 4
Naturally worn 4
Foreign material present in device 3
Defective item 3
Communication or transmission issue 3
Difficult to advance 3
Malfunction 3
Low readings 3
Device remains implanted 3
Unknown (for use when the device problem is not known) 3
Stretched 2
Material separation 2
Pacing inadequately 2
Premature elective replacement indicator 2
Premature deployment 2
Misconnection 2
Insulation degradation 2
Incorrect measurement 2
Material erosion 2
Explanted 2
Disconnection 2
Crack 2
Application interface becomes non-functional or program exits abnormally 2
Cut in material 2
Therapeutic or diagnostic output failure 2
No pacing 2
Noise, Audible 2
Failure to expand 1
Torn material 1
Total Device Problems 26586

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