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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 37

Device Problems
High impedance 3430
Oversensing 3354
Dislodged or dislocated 2073
Inappropriate shock 1872
Failure to capture 1635
Device sensing issue 1576
No code available 1439
No Known Device Problem 1367
Low impedance 1327
High capture threshold 1140
Fracture 1073
Break 1010
No Information 913
Failure to pace or properly pace 598
Ambient noise issue 523
Material integrity issue 498
Low sensing threshold 494
Impedance issue 336
Capturing issue 272
Undersensing 266
Device operates differently than expected 264
Connection issue 254
Decreased sensitivity 157
Failure to shock or properly shock 136
Artifact 129
High sensing threshold 129
Human-Device Interface Issue 110
Failure to sense 96
Device displays error message 81
Device Issue 73
Pocket stimulation 72
Failure to deploy 72
Loose or intermittent connection 71
Noise 71
Difficult to position 67
Failure to convert rhythm 59
Intermittent capture 59
Aborted charge 58
Invalid sensing 55
Difficult to remove 51
Migration of device or device component 47
Fitting problem 41
Use of Device Issue 40
Retraction problem 36
Nonstandard device or device component 34
Deployment issue 31
Difficult to insert 24
Positioning Issue 23
Electrical issue 22
Disinfection or Sterilization Issue at User Location 19
Loss of threshold 18
Sensing intermittently 17
Mechanical issue 16
Device damaged prior to use 16
Unstable capture threshold 16
Device alarm system issue 15
Dislodged 11
Electro-magnetic interference (EMI) 10
Device abrasion from instrument or another object 10
No device output 10
Short fill 10
Output issue 10
Device Contamination with biological material 8
Bent 8
Kinked 6
Device or device component damaged by another device 6
Component(s), broken 5
Normal 5
Failure to interrogate 4
Premature deployment 4
Device remains implanted 4
Difficult to deploy 4
Lead(s), fracture of 4
Malposition of device 4
Defective item 4
Naturally worn 4
Difficult to advance 3
Foreign material present in device 3
No pacing 3
Communication or transmission issue 3
Unknown (for use when the device problem is not known) 3
Malfunction 3
Low readings 3
Premature elective replacement indicator 3
Unable to obtain readings 2
Pacing inadequately 2
Misconnection 2
Material separation 2
Stretched 2
Incorrect measurement 2
Insulation degradation 2
Disconnection 2
Material erosion 2
Explanted 2
Accessory incompatible 2
Crack 2
Application interface becomes non-functional or program exits abnormally 2
Cut in material 2
Therapeutic or diagnostic output failure 2
Noise, Audible 2
Total Device Problems 27862

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