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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 27

Device Problems
High impedance 3230
Oversensing 3120
Dislodged or dislocated 1944
Inappropriate shock 1756
Failure to capture 1547
Device sensing issue 1538
No code available 1435
Low impedance 1294
No Known Device Problem 1159
High capture threshold 1069
Break 992
Fracture 992
No Information 903
Failure to pace or properly pace 578
Low sensing threshold 493
Material integrity issue 469
Ambient noise issue 407
Impedance issue 291
Device operates differently than expected 244
Connection issue 242
Undersensing 228
Capturing issue 209
Decreased sensitivity 156
Failure to shock or properly shock 133
High sensing threshold 126
Failure to sense 92
Artifact 85
Human-Device Interface Issue 83
Device displays error message 79
Device Issue 73
Loose or intermittent connection 70
Noise 68
Pocket stimulation 68
Difficult to position 65
Failure to deploy 62
Aborted charge 58
Intermittent capture 56
Invalid sensing 54
Failure to convert rhythm 53
Difficult to remove 47
Migration of device or device component 42
Fitting problem 40
Use of Device Issue 39
Retraction problem 36
Nonstandard device or device component 34
Difficult to insert 24
Electrical issue 20
Disinfection or Sterilization Issue at User Location 19
Loss of threshold 18
Sensing intermittently 17
Device damaged prior to use 16
Positioning Issue 14
Device alarm system issue 14
Deployment issue 13
Dislodged 11
Mechanical issue 10
Device abrasion from instrument or another object 10
Short fill 10
No device output 10
Output issue 10
Unstable capture threshold 9
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
Naturally worn 4
Defective item 3
Foreign material present in device 3
Difficult to advance 3
Communication or transmission issue 3
Malposition of device 3
Malfunction 3
Low readings 3
Unknown (for use when the device problem is not known) 3
Device remains implanted 3
Premature deployment 2
Pacing inadequately 2
Misconnection 2
Material separation 2
Insulation degradation 2
Incorrect measurement 2
Material erosion 2
Explanted 2
Crack 2
Application interface becomes non-functional or program exits abnormally 2
Therapeutic or diagnostic output failure 2
Noise, Audible 2
No pacing 2
Device handling issue 1
Failure to expand 1
Torn material 1
Programming issue 1
Protective measure issue 1
Inappropriate or unexpected reset 1
Total Device Problems 26103

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