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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 25

Device Problems
Dislodged or dislocated 3029
Failure to capture 2706
High impedance 1938
No code available 1733
Oversensing 1523
Device sensing issue 1405
Fracture 1280
No Known Device Problem 852
No Information 824
High capture threshold 817
Low impedance 736
Material integrity issue 619
Failure to pace or properly pace 488
Capturing issue 469
High sensing threshold 414
Failure to sense 380
Undersensing 334
Impedance issue 328
Difficult to position 305
Failure to deploy 236
Break 230
Ambient noise issue 211
Mechanical issue 170
Intermittent capture 158
Connection issue 156
Device operates differently than expected 145
Retraction problem 117
Pocket stimulation 109
Difficult to remove 103
Artifact 59
Electrical issue 50
Difficult to insert 48
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
Degraded 32
Unstable capture threshold 32
Noise 31
Bent 30
Low sensing 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
Deployment issue 22
Cut in material 21
Product quality issue 19
Device remains activated 19
Loose or intermittent connection 19
Kinked 18
Use of Device Issue 18
Failure to advance 18
Device abrasion from instrument or another object 16
Positioning Issue 16
No pacing 15
Device or device component damaged by another device 15
Other (for use when an appropriate device code cannot be identified) 15
Unknown (for use when the device problem is not known) 14
Invalid sensing 13
Steering wire problem 13
Difficult to advance 13
Device Contamination with biological material 12
Communication or transmission issue 11
Explanted 11
Material deformation 11
Component(s), broken 9
Mislabeled 9
Device contamination with blood or blood product 9
Out-of-box failure 8
Incomplete or missing packaging 8
Device displays error message 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
Pacing intermittently 6
Hole in material 6
Buckled material 6
Detachment of device or device component 5
Material separation 5
Device remains implanted 5
Collapse 5
Connection error 5
Incorrect measurement 5
Insulation, hole(s) in 5
Normal 4
Fitting problem 4
Implant, repositioning of 4
Low readings 4
Structural problem 4
Material twisted 4
Material Distortion 4
Total Device Problems 23043

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