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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 21

Device Problems
High impedance 3132
Oversensing 2974
Dislodged or dislocated 1837
Inappropriate shock 1676
Device sensing issue 1502
Failure to capture 1485
No code available 1432
Low impedance 1258
High capture threshold 1033
No Known Device Problem 996
Break 979
Fracture 939
No Information 892
Failure to pace or properly pace 554
Low sensing threshold 493
Material integrity issue 445
Ambient noise issue 305
Impedance issue 265
Connection issue 237
Device operates differently than expected 222
Undersensing 203
Capturing issue 164
Decreased sensitivity 156
High sensing threshold 125
Failure to shock or properly shock 124
Failure to sense 89
Device displays error message 76
Human-Device Interface Issue 75
Device Issue 73
Loose or intermittent connection 70
Artifact 69
Noise 68
Difficult to position 62
Pocket stimulation 61
Aborted charge 58
Failure to deploy 55
Invalid sensing 54
Intermittent capture 53
Difficult to remove 45
Failure to convert rhythm 45
Use of Device Issue 39
Migration of device or device component 38
Fitting problem 37
Retraction problem 35
Nonstandard device or device component 34
Difficult to insert 24
Electrical issue 19
Disinfection or Sterilization Issue at User Location 19
Sensing intermittently 17
Loss of threshold 16
Device damaged prior to use 16
Device alarm system issue 14
Dislodged 11
Device abrasion from instrument or another object 10
No device output 10
Short fill 10
Output issue 10
Mechanical issue 9
Electro-magnetic interference (EMI) 9
Bent 8
Deployment issue 8
Unstable capture threshold 7
Positioning Issue 5
Device or device component damaged by another device 5
Component(s), broken 5
Normal 5
Kinked 4
Lead(s), fracture of 4
Difficult to deploy 4
Device Contamination with biological material 4
Communication or transmission issue 3
Unknown (for use when the device problem is not known) 3
Malfunction 3
Low readings 3
Difficult to advance 3
Foreign material present in device 3
Naturally worn 3
Failure to interrogate 3
Device remains implanted 3
Incorrect measurement 2
Misconnection 2
Pacing inadequately 2
Material erosion 2
Explanted 2
Insulation degradation 2
Application interface becomes non-functional or program exits abnormally 2
Therapeutic or diagnostic output failure 2
No pacing 2
Noise, Audible 2
Malposition of device 2
Defective item 2
Delayed charge time 1
Arcing at electrodes 1
Split 1
Battery issue 1
Biological environmental factor 1
Failure to advance 1
Dent in material 1
Component missing 1
Radiofrequency interference (RFI) 1
Total Device Problems 24877

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