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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 3177
Oversensing 3061
Dislodged or dislocated 1883
Inappropriate shock 1727
Device sensing issue 1514
Failure to capture 1507
No code available 1435
Low impedance 1271
High capture threshold 1060
No Known Device Problem 1040
Break 988
Fracture 969
No Information 898
Failure to pace or properly pace 556
Low sensing threshold 493
Material integrity issue 448
Ambient noise issue 359
Impedance issue 282
Connection issue 239
Device operates differently than expected 233
Undersensing 221
Capturing issue 172
Decreased sensitivity 156
High sensing threshold 126
Failure to shock or properly shock 126
Failure to sense 91
Artifact 82
Device displays error message 78
Human-Device Interface Issue 76
Device Issue 73
Loose or intermittent connection 70
Noise 68
Pocket stimulation 62
Difficult to position 62
Failure to deploy 62
Aborted charge 58
Intermittent capture 56
Invalid sensing 54
Failure to convert rhythm 48
Difficult to remove 45
Migration of device or device component 41
Use of Device Issue 39
Fitting problem 37
Retraction problem 36
Nonstandard device or device component 34
Difficult to insert 24
Electrical issue 19
Disinfection or Sterilization Issue at User Location 19
Loss of threshold 18
Sensing intermittently 17
Device damaged prior to use 16
Device alarm system issue 14
Positioning Issue 13
Deployment issue 12
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
Component(s), broken 5
Normal 5
Device Contamination with biological material 5
Device or device component damaged by another device 5
Naturally worn 4
Failure to interrogate 4
Difficult to deploy 4
Lead(s), fracture of 4
Device remains implanted 3
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
Therapeutic or diagnostic output failure 2
No pacing 2
Noise, Audible 2
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
Degraded 1
Accessory incompatible 1
Disconnection 1
Detachment of device component 1
Failure to conduct 1
Connection error 1
Total Device Problems 25453

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