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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 3

Device Problems
Dislodged or dislocated 2143
Failure to capture 1339
No code available 1103
High impedance 856
Difficult to position 500
No Information 497
No Known Device Problem 469
High capture threshold 452
Fracture 448
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 98
Low impedance 89
Oversensing 88
Device remains activated 79
Impedance issue 72
Break 60
Difficult to remove 59
Device operates differently than expected 55
Device contamination with blood or blood product 41
Size incorrect for patient 37
Intermittent capture 35
Connection issue 35
Mechanical issue 29
Failure to sense 28
Use of Device Issue 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
Failure to advance 17
Device expiration issue 17
Defective item 16
Installation-related problem 13
Hole in material 13
Degraded 13
Normal 13
Device Contamination with biological material 11
Device handling issue 10
Difficult to deploy 10
Electrical issue 10
Artifact 9
Loose or intermittent connection 8
Loss of threshold 8
Cut in material 8
Disinfection or Sterilization Issue at User Location 7
Difficult to advance 7
Human-Device Interface Issue 7
Retraction problem 7
Explanted 7
Failure to deploy 6
Premature discharge of battery 6
Undersensing 6
Inappropriate shock 6
Kinked 6
Ambient noise issue 6
Device or device component damaged by another device 5
Programming issue 5
Stretched 5
Device inoperable 5
Material separation 5
Shelf life exceeded 5
Component(s), broken 5
Accessory incompatible 4
No pacing 4
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
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
Performance 2
Difficult to Program or Calibrate 2
Failure to shock or properly shock 2
Collapse 2
Fluid leak 2
Fitting problem 2
Unknown (for use when the device problem is not known) 2
Improper or incorrect procedure or method 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
Total Device Problems 10697

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