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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 15

Device Problems
Dislodged or dislocated 2011
Failure to capture 1272
No code available 1020
High impedance 805
Difficult to position 499
No Information 494
Fracture 430
No Known Device Problem 383
High capture threshold 340
Patient-device incompatibility 334
Pocket stimulation 306
Capturing issue 199
High sensing threshold 153
Material integrity issue 122
Device sensing issue 119
Difficult to insert 99
Failure to pace or properly pace 92
Low impedance 82
Deployment issue 81
Oversensing 80
Device remains activated 79
Positioning Issue 68
Difficult to remove 55
Device operates differently than expected 53
Impedance issue 50
Break 45
Device contamination with blood or blood product 40
Size incorrect for patient 37
Connection issue 31
Intermittent capture 29
Use of Device Issue 28
Failure to sense 27
Mechanical issue 27
Device damaged prior to use 26
Migration of device or device component 23
Dislodged 22
Other (for use when an appropriate device code cannot be identified) 22
Failure to advance 17
Device expiration issue 17
Defective item 16
Unstable capture threshold 15
Installation-related problem 13
Hole in material 13
Degraded 13
Normal 13
Device Contamination with biological material 11
Difficult to deploy 10
Electrical issue 9
Artifact 8
Loose or intermittent connection 8
Loss of threshold 8
Retraction problem 7
Explanted 7
Difficult to advance 7
Human-Device Interface Issue 7
Disinfection or Sterilization Issue at User Location 7
Cut in material 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
Device or device component damaged by another device 5
Ambient noise issue 5
Programming issue 5
Device handling 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
Material deformation 2
Foreign material present in device 2
Performance 2
Difficult to Program or Calibrate 2
Failure to shock or properly shock 2
Collapse 2
Fluid leak 2
Insulation degradation 1
Failure to interrogate 1
Total Device Problems 9944

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