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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 left ventricular (lv) pacemaker electrode
Definition Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Product CodeOJX
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
1 1 9 41 63 47 41 16 11 27 10

Device Problems
Dislodged or dislocated 2615
Failure to capture 1621
No code available 1284
High impedance 969
No Known Device Problem 836
High capture threshold 797
Difficult to position 509
No Information 503
Fracture 483
Patient-device incompatibility 334
Pocket stimulation 316
Capturing issue 292
Deployment issue 199
Positioning Issue 158
High sensing threshold 155
Break 144
Difficult to insert 135
Material integrity issue 134
Device sensing issue 124
Low impedance 119
Failure to pace or properly pace 111
Difficult to remove 106
Impedance issue 103
Oversensing 101
Device remains activated 79
Device operates differently than expected 68
Intermittent capture 53
Device contamination with blood or blood product 48
Connection issue 42
Unstable capture threshold 39
Size incorrect for patient 37
Failure to sense 34
Mechanical issue 29
Use of Device Issue 29
Device damaged prior to use 26
Migration of device or device component 25
Other (for use when an appropriate device code cannot be identified) 23
Dislodged 22
Failure to advance 19
Defective item 17
Device expiration issue 17
Artifact 16
No pacing 15
Degraded 14
Failure to deploy 14
Difficult to deploy 13
Hole in material 13
Normal 13
Installation-related problem 13
Device handling issue 12
Retraction problem 12
Device Contamination with biological material 11
Cut in material 10
Loss of threshold 10
Electrical issue 10
Accessory incompatible 9
Undersensing 9
Inappropriate shock 9
Ambient noise issue 9
Difficult to advance 8
Material separation 8
Loose or intermittent connection 8
Kinked 8
Explanted 7
Malposition of device 7
Disinfection or Sterilization Issue at User Location 7
Human-Device Interface Issue 7
Device or device component damaged by another device 6
Premature discharge of battery 6
Shelf life exceeded 6
Component(s), broken 5
Programming issue 5
Stretched 5
Device inoperable 5
Structural problem 4
Material deformation 4
Device-device incompatibility 4
Foreign material present in device 4
Bent 4
Device alarm system issue 3
Detachment of device component 3
Collapse 3
Electro-magnetic interference (EMI) 3
Sensing intermittently 3
Failure to shock or properly shock 3
Device remains implanted 3
Lead(s), fracture of 3
Pacing inadequately 3
Detachment of device or device component 3
Communication or transmission issue 3
Output issue 3
Reset issue 3
Obstruction within device 3
Unstable 3
Improper or incorrect procedure or method 3
Material perforation 3
Fitting problem 2
Unknown (for use when the device problem is not known) 2
Implant, reprogramming of 2
Electronic property issue 2
Total Device Problems 13144

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