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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 2017
12 27 30 82 89 92 96 86 52 39 8

Device Problems
Oversensing 3937
High impedance 3858
Dislodged or dislocated 2419
Inappropriate shock 2161
No Known Device Problem 1892
Failure to capture 1828
Device sensing issue 1697
Low impedance 1489
No code available 1444
High capture threshold 1369
Fracture 1200
Break 1160
No Information 929
Ambient noise issue 772
Failure to pace or properly pace 657
Material integrity issue 550
Low sensing threshold 500
Capturing issue 437
Impedance issue 411
Undersensing 329
Device operates differently than expected 299
Connection issue 259
Artifact 250
Decreased sensitivity 213
Failure to shock or properly shock 163
High sensing threshold 140
Human-Device Interface Issue 136
Failure to sense 113
Failure to deploy 112
Device displays error message 81
Pocket stimulation 80
Intermittent capture 74
Loose or intermittent connection 73
Device Issue 73
Difficult to position 72
Noise 71
Failure to convert rhythm 68
Migration of device or device component 60
Aborted charge 60
Difficult to remove 57
Invalid sensing 56
Retraction problem 51
Deployment issue 49
Fitting problem 47
Use of Device Issue 44
Positioning Issue 36
Nonstandard device or device component 34
Difficult to insert 29
Electrical issue 25
Unstable capture threshold 25
Sensing intermittently 20
Loss of threshold 19
Output issue 19
Disinfection or Sterilization Issue at User Location 19
Mechanical issue 18
Device abrasion from instrument or another object 18
Device alarm system issue 16
Device damaged prior to use 16
Device Contamination with biological material 14
Electro-magnetic interference (EMI) 12
Bent 11
Dislodged 11
No device output 10
Short fill 10
Device or device component damaged by another device 9
No pacing 8
Kinked 7
Difficult to deploy 6
Material deformation 6
Foreign material present in device 5
Defective item 5
Component(s), broken 5
Normal 5
Naturally worn 5
Failure to interrogate 4
Lead(s), fracture of 4
Premature elective replacement indicator 4
Premature deployment 4
Device remains implanted 4
Malposition of device 4
Therapeutic or diagnostic output failure 4
Cut in material 4
Low readings 3
Malfunction 3
Device contamination with blood or blood product 3
Stretched 3
Unknown (for use when the device problem is not known) 3
Difficult to advance 3
Communication or transmission issue 3
Material separation 3
Pacing inadequately 3
Material erosion 3
Device expiration issue 2
Explanted 2
Disconnection 2
Crack 2
Application interface becomes non-functional or program exits abnormally 2
Insulation degradation 2
Accessory incompatible 2
Collapse 2
Total Device Problems 32241

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