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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 2017
0 1 10 10 11 19 7 5 10 62 31

Device Problems
Dislodged or dislocated 4314
Failure to capture 3556
High impedance 2531
Oversensing 2161
No Known Device Problem 1838
No code available 1758
Device sensing issue 1705
Fracture 1560
Material integrity issue 1424
High capture threshold 1320
Capturing issue 1066
Low impedance 1008
No Information 912
Failure to pace or properly pace 703
Undersensing 557
Ambient noise issue 540
Impedance issue 491
Failure to sense 485
Difficult to position 448
High sensing threshold 427
Break 376
Device operates differently than expected 312
Failure to deploy 264
Human-Device Interface Issue 256
Intermittent capture 227
Artifact 194
Connection issue 187
Mechanical issue 180
Pocket stimulation 147
Difficult to remove 135
Retraction problem 132
Unstable capture threshold 79
Electrical issue 77
Decreased sensitivity 72
Difficult to insert 66
Sensing intermittently 44
Positioning Issue 43
Device Contamination with biological material 42
Bent 40
Degraded 39
Use of Device Issue 39
Device damaged prior to use 39
Deployment issue 36
Difficult to deploy 36
Device abrasion from instrument or another object 36
No pacing 35
Migration of device or device component 34
Patient-device incompatibility 34
Defective item 33
Inappropriate shock 33
Noise 30
Low sensing threshold 30
Product quality issue 28
Electrode(s), failure of 28
Dislodged 28
Loose or intermittent connection 27
Loss of threshold 26
Disinfection or Sterilization Issue at User Location 24
Cut in material 23
Invalid sensing 23
Electronic property issue 23
Kinked 20
Device remains activated 19
Device or device component damaged by another device 19
Failure to advance 18
Other (for use when an appropriate device code cannot be identified) 15
Unknown (for use when the device problem is not known) 14
Material deformation 14
Difficult to advance 13
Steering wire problem 13
Fitting problem 13
Malposition of device 12
Foreign material present in device 12
Communication or transmission issue 11
Explanted 11
Collapse 10
Pacing inadequately 10
Device contamination with blood or blood product 10
Structural problem 9
Device displays error message 9
Mislabeled 9
Component(s), broken 9
Out-of-box failure 8
Incomplete or missing packaging 8
Size incorrect for patient 8
Material separation 8
Output issue 8
Installation-related problem 7
Pacing intermittently 7
Misconnection 7
Hole in material 6
Detachment of device or device component 6
Material twisted 6
Buckled material 6
Device remains implanted 5
Electro-magnetic interference (EMI) 5
Connection error 5
Incorrect measurement 5
Insulation, hole(s) in 5
Device expiration issue 5
Total Device Problems 32746

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