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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 61

Device Problems
Dislodged or dislocated 5048
Failure to capture 4141
Oversensing 3205
High impedance 3013
No Known Device Problem 2929
Device sensing issue 1915
High capture threshold 1838
Fracture 1802
No code available 1787
Material integrity issue 1740
Capturing issue 1352
Low impedance 1317
No Information 943
Failure to pace or properly pace 788
Ambient noise issue 709
Undersensing 708
Break 647
Impedance issue 619
Failure to sense 580
Difficult to position 535
Device operates differently than expected 466
High sensing threshold 436
Artifact 417
Human-Device Interface Issue 311
Intermittent capture 303
Failure to deploy 298
Connection issue 200
Mechanical issue 189
Retraction problem 172
Pocket stimulation 165
Difficult to remove 157
Decreased sensitivity 127
Difficult to insert 112
Unstable capture threshold 108
Electrical issue 90
Positioning Issue 65
Device Contamination with biological material 59
Bent 57
Device abrasion from instrument or another object 56
No pacing 54
Sensing intermittently 50
Use of Device Issue 43
Low sensing threshold 42
Degraded 42
Difficult to deploy 41
Deployment issue 41
Electronic property issue 40
Device damaged prior to use 39
Inappropriate shock 35
Defective item 34
Migration of device or device component 34
Patient-device incompatibility 34
Product quality issue 32
Noise 30
Loss of threshold 30
Loose or intermittent connection 30
Dislodged 28
Electrode(s), failure of 28
Invalid sensing 26
Cut in material 25
Kinked 25
Disinfection or Sterilization Issue at User Location 24
Device or device component damaged by another device 24
Device remains activated 19
Failure to advance 18
Material deformation 18
Difficult to advance 16
Pacing inadequately 16
Device contamination with blood or blood product 15
Other (for use when an appropriate device code cannot be identified) 15
Foreign material present in device 15
Unknown (for use when the device problem is not known) 14
Fitting problem 13
Steering wire problem 13
Collapse 13
Material twisted 13
Malposition of device 12
Explanted 11
Electro-magnetic interference (EMI) 11
Pacing intermittently 11
Communication or transmission issue 11
Output issue 9
Mislabeled 9
Component(s), broken 9
Structural problem 9
Device displays error message 9
Out-of-box failure 8
Incomplete or missing packaging 8
Size incorrect for patient 8
Material separation 8
Detachment of device component 8
Misconnection 7
Installation-related problem 7
Detachment of device or device component 7
Buckled material 6
Hole in material 6
Incorrect measurement 6
Device expiration issue 6
Connection error 5
Crack 5
Total Device Problems 40629

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