• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Definition Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
Product CodeNVN
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 1 10 10 11 19 7 5 10 52

Device Problems
Dislodged or dislocated 3409
Failure to capture 2954
High impedance 2151
No code available 1742
Oversensing 1630
Device sensing issue 1489
Fracture 1364
No Known Device Problem 1072
High capture threshold 980
Material integrity issue 906
No Information 867
Low impedance 795
Capturing issue 638
Failure to pace or properly pace 556
High sensing threshold 415
Undersensing 414
Failure to sense 400
Impedance issue 368
Difficult to position 355
Ambient noise issue 305
Break 261
Failure to deploy 237
Device operates differently than expected 176
Intermittent capture 174
Mechanical issue 170
Connection issue 165
Retraction problem 117
Human-Device Interface Issue 117
Pocket stimulation 115
Difficult to remove 114
Artifact 85
Electrical issue 57
Unstable capture threshold 50
Difficult to insert 48
Decreased sensitivity 42
Device damaged prior to use 38
Degraded 38
Sensing intermittently 37
Patient-device incompatibility 34
Difficult to deploy 34
Defective item 33
Noise 32
Bent 30
Low sensing threshold 29
Electrode(s), failure of 28
Dislodged 28
Migration of device or device component 26
Deployment issue 26
Inappropriate shock 25
Disinfection or Sterilization Issue at User Location 24
Use of Device Issue 23
Product quality issue 23
Positioning Issue 23
Loss of threshold 22
Cut in material 22
Loose or intermittent connection 21
Device remains activated 19
Failure to advance 18
Kinked 18
No pacing 18
Device Contamination with biological material 18
Device abrasion from instrument or another object 16
Device or device component damaged by another device 16
Other (for use when an appropriate device code cannot be identified) 15
Unknown (for use when the device problem is not known) 14
Invalid sensing 13
Steering wire problem 13
Difficult to advance 13
Electronic property issue 12
Material deformation 12
Communication or transmission issue 11
Explanted 11
Malposition of device 10
Device contamination with blood or blood product 10
Device displays error message 9
Component(s), broken 9
Mislabeled 9
Pacing inadequately 8
Size incorrect for patient 8
Out-of-box failure 8
Incomplete or missing packaging 8
Foreign material present in device 8
Installation-related problem 7
Misconnection 7
Collapse 7
Hole in material 6
Pacing intermittently 6
Fitting problem 6
Material separation 6
Buckled material 6
Detachment of device or device component 5
Device remains implanted 5
Incorrect measurement 5
Insulation, hole(s) in 5
Connection error 5
Normal 4
Implant, repositioning of 4
Low readings 4
Structural problem 4
Material Distortion 4
Total Device Problems 25754

-
-