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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 10

Device Problems
Dislodged or dislocated 3740
Failure to capture 3165
High impedance 2315
No code available 1749
Oversensing 1726
Device sensing issue 1569
Fracture 1436
No Known Device Problem 1315
Material integrity issue 1170
High capture threshold 1070
No Information 893
Low impedance 836
Capturing issue 818
Failure to pace or properly pace 624
Undersensing 463
Ambient noise issue 431
High sensing threshold 415
Failure to sense 411
Impedance issue 403
Difficult to position 400
Break 276
Failure to deploy 237
Device operates differently than expected 211
Human-Device Interface Issue 195
Connection issue 178
Intermittent capture 178
Mechanical issue 173
Pocket stimulation 129
Difficult to remove 122
Retraction problem 117
Artifact 103
Electrical issue 61
Unstable capture threshold 57
Difficult to insert 48
Decreased sensitivity 45
Degraded 39
Sensing intermittently 38
Device damaged prior to use 38
Patient-device incompatibility 34
Difficult to deploy 34
Defective item 33
Use of Device Issue 32
Noise 32
Positioning Issue 31
Bent 30
Low sensing threshold 29
Device Contamination with biological material 29
Inappropriate shock 28
Electrode(s), failure of 28
Dislodged 28
Migration of device or device component 28
Deployment issue 26
Product quality issue 25
Loose or intermittent connection 24
Disinfection or Sterilization Issue at User Location 24
Loss of threshold 23
Cut in material 22
No pacing 20
Device remains activated 19
Failure to advance 18
Kinked 18
Device abrasion from instrument or another object 17
Device or device component damaged by another device 16
Other (for use when an appropriate device code cannot be identified) 15
Electronic property issue 15
Unknown (for use when the device problem is not known) 14
Invalid sensing 13
Steering wire problem 13
Difficult to advance 13
Material deformation 12
Communication or transmission issue 11
Malposition of device 11
Explanted 11
Device displays error message 10
Device contamination with blood or blood product 10
Fitting problem 9
Collapse 9
Component(s), broken 9
Mislabeled 9
Pacing inadequately 8
Out-of-box failure 8
Incomplete or missing packaging 8
Size incorrect for patient 8
Material separation 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
Device remains implanted 5
Connection error 5
Incorrect measurement 5
Insulation, hole(s) in 5
Material twisted 5
Material Distortion 4
Normal 4
Electro-magnetic interference (EMI) 4
Implant, repositioning of 4
Total Device Problems 28152

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