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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 2175
Failure to capture 1355
No code available 1141
High impedance 860
High capture threshold 507
Difficult to position 500
No Information 498
No Known Device Problem 483
Fracture 447
Patient-device incompatibility 334
Pocket stimulation 311
Capturing issue 229
High sensing threshold 154
Deployment issue 133
Material integrity issue 127
Device sensing issue 119
Positioning Issue 109
Failure to pace or properly pace 100
Difficult to insert 99
Low impedance 92
Oversensing 86
Device remains activated 79
Impedance issue 73
Break 72
Difficult to remove 58
Device operates differently than expected 55
Device contamination with blood or blood product 43
Connection issue 37
Size incorrect for patient 37
Intermittent capture 37
Mechanical issue 29
Use of Device Issue 29
Failure to sense 28
Device damaged prior to use 26
Migration of device or device component 24
Other (for use when an appropriate device code cannot be identified) 23
Dislodged 22
Unstable capture threshold 21
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 11
Difficult to deploy 10
Artifact 10
Electrical issue 9
Loose or intermittent connection 8
Loss of threshold 8
Cut in material 8
Undersensing 7
Disinfection or Sterilization Issue at User Location 7
Difficult to advance 7
Human-Device Interface Issue 7
Retraction problem 7
Kinked 7
Explanted 7
Failure to deploy 6
Premature discharge of battery 6
Shelf life exceeded 6
Inappropriate shock 6
Ambient noise issue 6
Malposition of device 5
Device inoperable 5
Stretched 5
Device or device component damaged by another device 5
Programming issue 5
Material separation 5
Accessory incompatible 5
Component(s), broken 5
No pacing 4
Reset issue 3
Output issue 3
Device-device incompatibility 3
Unstable 3
Material perforation 3
Obstruction within device 3
Communication or transmission issue 3
Device alarm system issue 3
Bent 3
Electro-magnetic interference (EMI) 3
Sensing intermittently 3
Device remains implanted 3
Lead(s), fracture of 3
Performance 2
Difficult to Program or Calibrate 2
Material puncture 2
Failure to shock or properly shock 2
Collapse 2
Fluid leak 2
Detachment of device or device component 2
Implant, reprogramming of 2
Improper or incorrect procedure or method 2
Fitting problem 2
Unknown (for use when the device problem is not known) 2
Material deformation 2
Electronic property issue 2
Total Device Problems 10917

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