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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 4

Device Problems
Dislodged or dislocated 1861
Failure to capture 1208
No code available 907
High impedance 761
Difficult to position 499
No Information 484
Fracture 409
Patient-device incompatibility 334
No Known Device Problem 329
Pocket stimulation 306
High capture threshold 217
Capturing issue 168
High sensing threshold 152
Device sensing issue 118
Material integrity issue 117
Difficult to insert 99
Failure to pace or properly pace 89
Device remains activated 79
Oversensing 76
Low impedance 70
Difficult to remove 49
Device operates differently than expected 47
Device contamination with blood or blood product 39
Impedance issue 39
Size incorrect for patient 37
Break 32
Use of Device Issue 28
Positioning Issue 28
Connection issue 27
Failure to sense 27
Device damaged prior to use 26
Migration of device or device component 23
Other (for use when an appropriate device code cannot be identified) 22
Intermittent capture 22
Dislodged 22
Deployment issue 22
Mechanical issue 20
Device expiration issue 17
Failure to advance 17
Defective item 15
Installation-related problem 13
Hole in material 13
Degraded 13
Normal 13
Unstable capture threshold 11
Device Contamination with biological material 11
Electrical issue 10
Loss of threshold 8
Retraction problem 7
Explanted 7
Difficult to deploy 7
Difficult to advance 7
Disinfection or Sterilization Issue at User Location 7
Human-Device Interface Issue 7
Cut in material 6
Loose or intermittent connection 6
Kinked 6
Undersensing 6
Device inoperable 5
Inappropriate shock 5
Failure to deploy 5
Component(s), broken 5
Premature discharge of battery 5
Programming issue 5
No pacing 4
Device or device component damaged by another device 4
Artifact 4
Material separation 4
Stretched 4
Unstable 3
Shelf life exceeded 3
Sensing intermittently 3
Device remains implanted 3
Device alarm system issue 3
Bent 3
Lead(s), fracture of 3
Device-device incompatibility 3
Communication or transmission issue 3
Ambient noise issue 3
Material perforation 3
Obstruction within device 3
Malposition of device 3
Reset issue 3
Output issue 3
Implant, reprogramming of 2
Detachment of device or device component 2
Foreign material present in device 2
Fluid leak 2
Performance 2
Difficult to Program or Calibrate 2
Failure to shock or properly shock 2
Fitting problem 2
Unknown (for use when the device problem is not known) 2
Noise 1
Shipping damage or problem 1
Uncoiled 1
Slippage of device or device component 1
Sticking 1
Material puncture 1
Rejection 1
Total Device Problems 9120

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