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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 0

Device Problems
Dislodged or dislocated 2141
Failure to capture 1336
No code available 1103
High impedance 855
Difficult to position 500
No Information 497
No Known Device Problem 465
High capture threshold 450
Fracture 447
Patient-device incompatibility 334
Pocket stimulation 310
Capturing issue 224
High sensing threshold 154
Material integrity issue 126
Device sensing issue 123
Deployment issue 112
Failure to pace or properly pace 102
Difficult to insert 99
Positioning Issue 97
Low impedance 89
Oversensing 88
Device remains activated 79
Impedance issue 71
Break 60
Difficult to remove 59
Device operates differently than expected 54
Device contamination with blood or blood product 41
Size incorrect for patient 37
Connection issue 35
Intermittent capture 33
Mechanical issue 29
Use of Device Issue 28
Failure to sense 28
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
Unstable capture threshold 19
Device expiration issue 17
Failure to advance 17
Defective item 16
Normal 13
Installation-related problem 13
Hole in material 13
Degraded 13
Device Contamination with biological material 11
Difficult to deploy 10
Electrical issue 10
Artifact 9
Device handling issue 9
Loss of threshold 8
Cut in material 8
Loose or intermittent connection 8
Difficult to advance 7
Retraction problem 7
Explanted 7
Disinfection or Sterilization Issue at User Location 7
Human-Device Interface Issue 7
Inappropriate shock 6
Premature discharge of battery 6
Kinked 6
Ambient noise issue 6
Failure to deploy 6
Undersensing 6
Material separation 5
Device or device component damaged by another device 5
Shelf life exceeded 5
Stretched 5
Component(s), broken 5
Device inoperable 5
Programming issue 5
No pacing 4
Accessory incompatible 4
Reset issue 3
Sensing intermittently 3
Device-device incompatibility 3
Device remains implanted 3
Electro-magnetic interference (EMI) 3
Material perforation 3
Output issue 3
Lead(s), fracture of 3
Device alarm system issue 3
Malposition of device 3
Obstruction within device 3
Communication or transmission issue 3
Bent 3
Unstable 3
Improper or incorrect procedure or method 2
Performance 2
Electronic property issue 2
Unknown (for use when the device problem is not known) 2
Difficult to Program or Calibrate 2
Failure to shock or properly shock 2
Detachment of device or device component 2
Collapse 2
Fluid leak 2
Implant, reprogramming of 2
Fitting problem 2
Material deformation 2
Foreign material present in device 2
Total Device Problems 10678

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