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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
1 1 9 41 63 47 41 16 11 22

Device Problems
Dislodged or dislocated 2094
Failure to capture 1305
No code available 1066
High impedance 837
Difficult to position 500
No Information 497
Fracture 439
No Known Device Problem 426
High capture threshold 394
Patient-device incompatibility 334
Pocket stimulation 309
Capturing issue 209
High sensing threshold 154
Material integrity issue 125
Device sensing issue 122
Difficult to insert 99
Failure to pace or properly pace 96
Deployment issue 92
Positioning Issue 86
Low impedance 84
Oversensing 84
Device remains activated 79
Impedance issue 64
Difficult to remove 58
Break 55
Device operates differently than expected 53
Device contamination with blood or blood product 41
Size incorrect for patient 37
Connection issue 34
Intermittent capture 32
Mechanical issue 29
Use of Device Issue 28
Failure to sense 27
Device damaged prior to use 26
Migration of device or device component 24
Other (for use when an appropriate device code cannot be identified) 23
Dislodged 22
Device expiration issue 17
Failure to advance 17
Unstable capture threshold 17
Defective item 16
Installation-related problem 13
Hole in material 13
Degraded 13
Normal 13
Device Contamination with biological material 11
Difficult to deploy 10
Electrical issue 10
Artifact 9
Device handling issue 9
Cut in material 8
Loose or intermittent connection 8
Loss of threshold 8
Retraction problem 7
Explanted 7
Disinfection or Sterilization Issue at User Location 7
Difficult to advance 7
Human-Device Interface Issue 7
Premature discharge of battery 6
Undersensing 6
Inappropriate shock 6
Kinked 6
Stretched 5
Device inoperable 5
Material separation 5
Shelf life exceeded 5
Component(s), broken 5
Failure to deploy 5
Programming issue 5
Device or device component damaged by another device 5
Ambient noise issue 5
No pacing 4
Accessory incompatible 4
Device alarm system issue 3
Bent 3
Electro-magnetic interference (EMI) 3
Sensing intermittently 3
Unstable 3
Lead(s), fracture of 3
Device remains implanted 3
Reset issue 3
Output issue 3
Device-device incompatibility 3
Communication or transmission issue 3
Malposition of device 3
Obstruction within device 3
Material perforation 3
Fitting problem 2
Unknown (for use when the device problem is not known) 2
Implant, reprogramming of 2
Detachment of device or device component 2
Electronic property issue 2
Foreign material present in device 2
Material deformation 2
Performance 2
Difficult to Program or Calibrate 2
Failure to shock or properly shock 2
Collapse 2
Fluid leak 2
Insulation degradation 1
Total Device Problems 10355

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