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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 34

Device Problems
Dislodged or dislocated 3100
Failure to capture 2761
High impedance 1984
No code available 1736
Oversensing 1556
Device sensing issue 1410
Fracture 1298
High capture threshold 889
No Known Device Problem 879
No Information 840
Low impedance 757
Material integrity issue 625
Failure to pace or properly pace 501
Capturing issue 485
High sensing threshold 414
Failure to sense 385
Undersensing 370
Impedance issue 343
Difficult to position 306
Break 246
Failure to deploy 237
Ambient noise issue 227
Mechanical issue 170
Intermittent capture 163
Connection issue 157
Device operates differently than expected 147
Retraction problem 117
Pocket stimulation 109
Difficult to remove 103
Artifact 72
Electrical issue 50
Difficult to insert 48
Human-Device Interface Issue 48
Unstable capture threshold 41
Decreased sensitivity 39
Device damaged prior to use 38
Sensing intermittently 37
Degraded 35
Difficult to deploy 34
Patient-device incompatibility 34
Defective item 33
Noise 31
Bent 30
Low sensing threshold 29
Electrode(s), failure of 28
Dislodged 28
Migration of device or device component 25
Disinfection or Sterilization Issue at User Location 24
Deployment issue 24
Inappropriate shock 24
Loss of threshold 22
Cut in material 22
Positioning Issue 21
Loose or intermittent connection 20
Product quality issue 19
Device remains activated 19
Use of Device Issue 18
Failure to advance 18
Kinked 18
No pacing 17
Device or device component damaged by another device 16
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
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
Device contamination with blood or blood product 10
Malposition of device 9
Component(s), broken 9
Mislabeled 9
Pacing inadequately 8
Device displays error message 8
Out-of-box failure 8
Incomplete or missing packaging 8
Size incorrect for patient 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
Electronic property issue 5
Material Distortion 4
Material twisted 4
Normal 4
Fitting problem 4
Implant, repositioning of 4
Low readings 4
Total Device Problems 23587

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