• 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 4

Device Problems
Dislodged or dislocated 3537
Failure to capture 3047
High impedance 2219
No code available 1749
Oversensing 1688
Device sensing issue 1519
Fracture 1408
No Known Device Problem 1137
High capture threshold 1055
Material integrity issue 963
No Information 887
Low impedance 822
Capturing issue 684
Failure to pace or properly pace 583
Undersensing 444
High sensing threshold 415
Failure to sense 406
Impedance issue 390
Difficult to position 363
Ambient noise issue 362
Break 271
Failure to deploy 237
Device operates differently than expected 189
Intermittent capture 178
Mechanical issue 173
Connection issue 170
Human-Device Interface Issue 141
Pocket stimulation 120
Retraction problem 117
Difficult to remove 115
Artifact 102
Electrical issue 59
Unstable capture threshold 56
Difficult to insert 48
Decreased sensitivity 45
Degraded 39
Device damaged prior to use 38
Sensing intermittently 37
Patient-device incompatibility 34
Difficult to deploy 34
Defective item 33
Noise 32
Positioning Issue 31
Bent 30
Low sensing threshold 29
Inappropriate shock 28
Electrode(s), failure of 28
Dislodged 28
Migration of device or device component 27
Deployment issue 26
Disinfection or Sterilization Issue at User Location 24
Use of Device Issue 24
Loose or intermittent connection 24
Product quality issue 23
Loss of threshold 23
Cut in material 22
Device Contamination with biological material 20
Device remains activated 19
Failure to advance 18
Kinked 18
No pacing 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
Electronic property issue 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
Communication or transmission issue 11
Malposition of device 11
Explanted 11
Device displays error message 10
Device contamination with blood or blood product 10
Collapse 9
Component(s), broken 9
Mislabeled 9
Pacing inadequately 8
Size incorrect for patient 8
Material separation 8
Out-of-box failure 8
Incomplete or missing packaging 8
Foreign material present in device 8
Installation-related problem 7
Misconnection 7
Pacing intermittently 6
Hole in material 6
Fitting problem 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
Normal 4
Electro-magnetic interference (EMI) 4
Implant, repositioning of 4
Total Device Problems 26745

-
-