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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 13

Device Problems
Oversensing 4802
High impedance 4481
Dislodged or dislocated 2861
No Known Device Problem 2647
Inappropriate shock 2495
Failure to capture 2122
Device sensing issue 1883
High capture threshold 1693
Low impedance 1642
No code available 1454
Break 1405
Fracture 1380
Ambient noise issue 1000
No Information 934
Failure to pace or properly pace 737
Capturing issue 608
Material integrity issue 606
Low sensing threshold 524
Impedance issue 512
Artifact 450
Undersensing 387
Device operates differently than expected 352
Decreased sensitivity 292
Connection issue 267
Failure to shock or properly shock 194
Failure to deploy 183
Human-Device Interface Issue 161
High sensing threshold 149
Failure to sense 145
Intermittent capture 107
Retraction problem 97
Pocket stimulation 91
Difficult to position 84
Device displays error message 83
Failure to convert rhythm 82
Loose or intermittent connection 75
Device Issue 73
Difficult to remove 72
Noise 71
Deployment issue 68
Migration of device or device component 63
Aborted charge 62
Invalid sensing 56
Fitting problem 49
Positioning Issue 49
Difficult to insert 47
Use of Device Issue 44
Unstable capture threshold 43
Nonstandard device or device component 34
Device abrasion from instrument or another object 33
Electrical issue 33
Mechanical issue 29
Output issue 28
Sensing intermittently 23
Device Contamination with biological material 21
Loss of threshold 21
Disinfection or Sterilization Issue at User Location 19
Electro-magnetic interference (EMI) 19
Bent 17
Device alarm system issue 17
Device damaged prior to use 16
Device or device component damaged by another device 12
Dislodged 11
Kinked 11
No device output 11
Short fill 10
Difficult to deploy 9
Therapeutic or diagnostic output failure 9
No pacing 8
Pacing inadequately 8
Foreign material present in device 8
Material deformation 7
Cut in material 6
Defective item 5
Failure to interrogate 5
Normal 5
Component(s), broken 5
Naturally worn 5
Collapse 4
Lead(s), fracture of 4
Premature elective replacement indicator 4
Premature deployment 4
Material separation 4
Device remains implanted 4
Malposition of device 4
Device contamination with blood or blood product 4
Stretched 4
Unexpected therapeutic results 3
Unknown (for use when the device problem is not known) 3
Low readings 3
Failure to advance 3
Malfunction 3
Communication or transmission issue 3
Battery issue 3
Device-device incompatibility 3
Difficult to advance 3
Pacing intermittently 3
Accessory incompatible 3
Material erosion 3
Noise, Audible 3
Total Device Problems 38202

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