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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 4

Device Problems
High impedance 3550
Oversensing 3510
Dislodged or dislocated 2187
Inappropriate shock 1951
Failure to capture 1697
Device sensing issue 1616
No Known Device Problem 1555
No code available 1440
Low impedance 1367
High capture threshold 1179
Fracture 1118
Break 1022
No Information 923
Ambient noise issue 639
Failure to pace or properly pace 622
Material integrity issue 518
Low sensing threshold 494
Impedance issue 355
Capturing issue 336
Undersensing 297
Device operates differently than expected 275
Connection issue 257
Decreased sensitivity 165
Artifact 159
Failure to shock or properly shock 138
High sensing threshold 129
Human-Device Interface Issue 122
Failure to sense 98
Device displays error message 82
Failure to deploy 80
Pocket stimulation 74
Device Issue 73
Noise 71
Loose or intermittent connection 71
Difficult to position 67
Failure to convert rhythm 60
Intermittent capture 59
Aborted charge 58
Invalid sensing 55
Migration of device or device component 53
Difficult to remove 52
Fitting problem 43
Use of Device Issue 42
Retraction problem 36
Deployment issue 35
Nonstandard device or device component 34
Positioning Issue 27
Difficult to insert 24
Electrical issue 24
Disinfection or Sterilization Issue at User Location 19
Loss of threshold 18
Sensing intermittently 18
Mechanical issue 17
Unstable capture threshold 17
Device damaged prior to use 16
Device alarm system issue 16
Electro-magnetic interference (EMI) 12
Dislodged 11
Device abrasion from instrument or another object 10
No device output 10
Short fill 10
Device Contamination with biological material 10
Output issue 10
Bent 8
Device or device component damaged by another device 7
Kinked 6
Component(s), broken 5
Normal 5
Naturally worn 5
Malposition of device 4
Defective item 4
Failure to interrogate 4
Premature deployment 4
Device remains implanted 4
Difficult to deploy 4
Lead(s), fracture of 4
Material separation 3
Stretched 3
Premature elective replacement indicator 3
Communication or transmission issue 3
Unknown (for use when the device problem is not known) 3
Malfunction 3
Cut in material 3
Low readings 3
Difficult to advance 3
Foreign material present in device 3
No pacing 3
Therapeutic or diagnostic output failure 2
Noise, Audible 2
Material deformation 2
Device contamination with blood or blood product 2
Unable to obtain readings 2
Pacing inadequately 2
Misconnection 2
Incorrect measurement 2
Insulation degradation 2
Disconnection 2
Material erosion 2
Explanted 2
Accessory incompatible 2
Total Device Problems 29156

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