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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Definition Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
Product CodeNVN
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 1 10 10 11 19 7 5 10 12

Device Problems
Dislodged or dislocated 2912
Failure to capture 2645
High impedance 1887
No code available 1726
Oversensing 1477
Device sensing issue 1395
Fracture 1241
No Known Device Problem 804
No Information 800
High capture threshold 736
Low impedance 703
Material integrity issue 597
Failure to pace or properly pace 472
Capturing issue 450
High sensing threshold 414
Failure to sense 374
Impedance issue 316
Undersensing 309
Difficult to position 304
Failure to deploy 235
Break 213
Ambient noise issue 178
Mechanical issue 168
Intermittent capture 155
Connection issue 154
Device operates differently than expected 141
Retraction problem 117
Pocket stimulation 107
Difficult to remove 103
Electrical issue 50
Difficult to insert 48
Artifact 46
Human-Device Interface Issue 45
Decreased sensitivity 39
Device damaged prior to use 38
Sensing intermittently 37
Patient-device incompatibility 34
Difficult to deploy 34
Defective item 33
Noise 32
Degraded 30
Bent 29
Low sensing threshold 29
Unstable capture threshold 29
Electrode(s), failure of 28
Dislodged 28
Migration of device or device component 24
Disinfection or Sterilization Issue at User Location 24
Inappropriate shock 24
Loss of threshold 22
Cut in material 21
Deployment issue 20
Product quality issue 19
Device remains activated 19
Failure to advance 18
Kinked 18
Loose or intermittent connection 17
Use of Device Issue 17
Device abrasion from instrument or another object 16
Other (for use when an appropriate device code cannot be identified) 15
Unknown (for use when the device problem is not known) 14
No pacing 14
Difficult to advance 13
Invalid sensing 13
Steering wire problem 13
Device Contamination with biological material 12
Material deformation 11
Communication or transmission issue 11
Explanted 11
Positioning Issue 10
Component(s), broken 9
Mislabeled 9
Device or device component damaged by another device 9
Device contamination with blood or blood product 9
Out-of-box failure 8
Incomplete or missing packaging 8
Malposition of device 8
Size incorrect for patient 8
Pacing inadequately 8
Foreign material present in device 8
Installation-related problem 7
Misconnection 7
Device displays error message 7
Buckled material 6
Pacing intermittently 6
Hole in material 6
Connection error 5
Incorrect measurement 5
Insulation, hole(s) in 5
Detachment of device or device component 5
Device remains implanted 5
Material separation 4
Fitting problem 4
Implant, repositioning of 4
Low readings 4
Structural problem 4
Normal 4
Material Distortion 4
Material twisted 4
Insulation, detached 3
Total Device Problems 22321

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