• 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 2017
0 1 10 10 11 19 7 5 10 62 12

Device Problems
Dislodged or dislocated 3781
Failure to capture 3201
High impedance 2327
Oversensing 1750
No code available 1748
Device sensing issue 1570
Fracture 1449
No Known Device Problem 1333
Material integrity issue 1175
High capture threshold 1102
No Information 896
Low impedance 858
Capturing issue 824
Failure to pace or properly pace 628
Undersensing 479
Ambient noise issue 436
Impedance issue 423
Failure to sense 420
High sensing threshold 416
Difficult to position 400
Break 283
Failure to deploy 239
Device operates differently than expected 216
Human-Device Interface Issue 196
Intermittent capture 183
Connection issue 179
Mechanical issue 173
Pocket stimulation 131
Difficult to remove 122
Retraction problem 117
Artifact 112
Unstable capture threshold 67
Electrical issue 61
Difficult to insert 48
Decreased sensitivity 47
Degraded 39
Sensing intermittently 38
Device damaged prior to use 38
Positioning Issue 35
Patient-device incompatibility 34
Difficult to deploy 34
Defective item 33
Use of Device Issue 32
Bent 31
Noise 30
Low sensing threshold 29
Deployment issue 29
Device Contamination with biological material 29
Inappropriate shock 28
Electrode(s), failure of 28
Dislodged 28
Migration of device or device component 28
Product quality issue 25
Loose or intermittent connection 24
Disinfection or Sterilization Issue at User Location 24
Cut in material 23
Loss of threshold 23
No pacing 21
Device abrasion from instrument or another object 20
Device remains activated 19
Electronic property issue 19
Failure to advance 18
Kinked 18
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
Material deformation 12
Malposition of device 12
Communication or transmission issue 11
Explanted 11
Collapse 10
Device contamination with blood or blood product 10
Device displays error message 9
Fitting problem 9
Component(s), broken 9
Mislabeled 9
Pacing inadequately 8
Out-of-box failure 8
Incomplete or missing packaging 8
Size incorrect for patient 8
Material separation 8
Foreign material present in device 8
Installation-related problem 7
Pacing intermittently 7
Misconnection 7
Hole in material 6
Buckled material 6
Detachment of device or device component 5
Device remains implanted 5
Connection error 5
Incorrect measurement 5
Insulation, hole(s) in 5
Material twisted 5
Material Distortion 4
Device expiration issue 4
Normal 4
Electro-magnetic interference (EMI) 4
Total Device Problems 28480

-
-