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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 12

Device Problems
Dislodged or dislocated 1945
Failure to capture 1244
No code available 966
High impedance 790
Difficult to position 499
No Information 488
Fracture 424
No Known Device Problem 361
Patient-device incompatibility 334
Pocket stimulation 306
High capture threshold 279
Capturing issue 186
High sensing threshold 153
Material integrity issue 120
Device sensing issue 119
Difficult to insert 99
Failure to pace or properly pace 90
Device remains activated 79
Low impedance 77
Oversensing 75
Device operates differently than expected 51
Positioning Issue 51
Difficult to remove 49
Deployment issue 47
Impedance issue 44
Break 41
Device contamination with blood or blood product 39
Size incorrect for patient 37
Connection issue 31
Use of Device Issue 28
Failure to sense 27
Intermittent capture 27
Device damaged prior to use 26
Mechanical issue 24
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 15
Unstable capture threshold 14
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
Loss of threshold 8
Retraction problem 7
Loose or intermittent connection 7
Explanted 7
Artifact 7
Disinfection or Sterilization Issue at User Location 7
Cut in material 7
Difficult to advance 7
Human-Device Interface Issue 7
Premature discharge of battery 6
Kinked 6
Inappropriate shock 6
Undersensing 6
Device inoperable 5
Failure to deploy 5
Component(s), broken 5
Programming issue 5
Stretched 5
Device or device component damaged by another device 5
Ambient noise issue 4
No pacing 4
Material separation 4
Shelf life exceeded 4
Sensing intermittently 3
Unstable 3
Device remains implanted 3
Bent 3
Accessory incompatible 3
Device alarm system issue 3
Electro-magnetic interference (EMI) 3
Lead(s), fracture of 3
Reset issue 3
Output issue 3
Device-device incompatibility 3
Obstruction within device 3
Malposition of device 3
Communication or transmission issue 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
Foreign material present in device 2
Material deformation 2
Fluid leak 2
Difficult to Program or Calibrate 2
Performance 2
Failure to shock or properly shock 2
Shipping damage or problem 1
Sensitivity 1
Noise 1
Uncoiled 1
Total Device Problems 9571

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