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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
Oversensing 3573
High impedance 3567
Dislodged or dislocated 2210
Inappropriate shock 1981
Failure to capture 1706
Device sensing issue 1612
No Known Device Problem 1574
No code available 1442
Low impedance 1369
High capture threshold 1204
Fracture 1133
Break 1029
No Information 922
Ambient noise issue 656
Failure to pace or properly pace 624
Material integrity issue 517
Low sensing threshold 494
Impedance issue 364
Capturing issue 340
Undersensing 306
Device operates differently than expected 276
Connection issue 255
Artifact 179
Decreased sensitivity 170
Failure to shock or properly shock 139
High sensing threshold 129
Human-Device Interface Issue 122
Failure to sense 100
Failure to deploy 87
Device displays error message 81
Pocket stimulation 74
Device Issue 73
Noise 71
Loose or intermittent connection 71
Difficult to position 67
Intermittent capture 61
Failure to convert rhythm 60
Aborted charge 58
Invalid sensing 55
Migration of device or device component 54
Difficult to remove 53
Fitting problem 43
Use of Device Issue 42
Deployment issue 40
Retraction problem 36
Nonstandard device or device component 34
Positioning Issue 29
Electrical issue 24
Difficult to insert 24
Unstable capture threshold 19
Disinfection or Sterilization Issue at User Location 19
Loss of threshold 18
Mechanical issue 18
Sensing intermittently 18
Device alarm system issue 16
Device damaged prior to use 16
Device abrasion from instrument or another object 13
Electro-magnetic interference (EMI) 12
Dislodged 11
Bent 10
No device output 10
Short fill 10
Device Contamination with biological material 10
Output issue 10
Device or device component damaged by another device 7
Kinked 6
Component(s), broken 5
Normal 5
Naturally worn 5
No pacing 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 erosion 3
Material separation 3
Stretched 3
Premature elective replacement indicator 3
Device contamination with blood or blood product 3
Communication or transmission issue 3
Malfunction 3
Cut in material 3
Low readings 3
Unknown (for use when the device problem is not known) 3
Material deformation 3
Difficult to advance 3
Foreign material present in device 3
Noise, Audible 2
Therapeutic or diagnostic output failure 2
Pacing inadequately 2
Misconnection 2
Incorrect measurement 2
Unable to obtain readings 2
Explanted 2
Disconnection 2
Insulation degradation 2
Accessory incompatible 2
Total Device Problems 29460

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