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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device permanent pacemaker electrode
Regulation Description Cardiovascular permanent or temporary pacemaker electrode.
Product CodeDTB
Regulation Number 870.3680
Device Class 3


Premarket Reviews
ManufacturerDecision
BIOTRONIK GMBG & CO.
  12
  SUBSTANTIALLY EQUIVALENT 14
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 13
DIAG CORP.
  SUBSTANTIALLY EQUIVALENT 5
ELA MEDICAL, INC.
  3
  SUBSTANTIALLY EQUIVALENT 8
INTERMEDICS
  SE - POSTMARKET SURVEILLANCE REQUIRED 2
  6
  SUBSTANTIALLY EQUIVALENT 97
MEDTRONIC, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 5
  7
  SUBSTANTIALLY EQUIVALENT 58
OSCOR, INC.
  2
  SUBSTANTIALLY EQUIVALENT 18
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
SCHOLTEN SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3
ST. JUDE MEDICAL, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 2
  4
  SUBSTANTIALLY EQUIVALENT 28
TELECTRONICS
  2
  SUBSTANTIALLY EQUIVALENT 8
VASCOR MEDICAL CORP.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  SUBSTANTIALLY EQUIVALENT 2

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 3 8 0

Device Problems
High impedance 8685
Failure to capture 7958
Dislodged or dislocated 5688
Oversensing 5112
Low impedance 4641
High sensing threshold 4504
No Known Device Problem 4058
Dislodged 3761
Capturing issue 3246
High capture threshold 3063
Fracture 2714
No code available 2588
Device damaged prior to use 2433
Normal 2307
Undersensing 2259
Difficult to position 2127
Impedance issue 1915
Failure to pace or properly pace 1729
Artifact 1543
Noise 1485
Failure to sense 1338
Device remains activated 1320
Device sensing issue 1304
Loss of threshold 1208
Intermittent capture 1039
Explanted 1021
Lead(s), fracture of 952
No Information 860
Unknown (for use when the device problem is not known) 845
Retraction problem 832
Failure to advance 737
Device remains implanted 728
Pocket stimulation 717
Failure to deploy 707
Patient-device incompatibility 669
Material integrity issue 640
Other (for use when an appropriate device code cannot be identified) 532
Break 528
Mechanical issue 480
Defective item 480
Sensing intermittently 461
Ambient noise issue 457
Deployment issue 439
Degraded 436
Positioning Issue 415
Implant, reprogramming of 363
Implant, repositioning of 339
Unstable capture threshold 333
Invalid sensing 322
Low sensing threshold 318
Inappropriate shock 309
Device operates differently than expected 287
Insulation, hole(s) in 244
Sensitivity 241
Difficult to insert 240
Difficult to remove 236
Decreased sensitivity 220
Insulation degradation 210
Connection error 203
Performance 200
Low readings 196
Cut in material 190
Material perforation 178
Connection issue 167
Difficult to deploy 165
Interference 162
Malfunction 160
Bent 132
Application interface becomes non-functional or program exits abnormally 125
Electrical issue 115
Size incorrect for patient 112
Hole in material 108
No pacing 108
Pacing inadequately 106
Electronic property issue 105
Device contamination with blood or blood product 104
Crack 100
Insulation failure 92
Migration of device or device component 84
Human-Device Interface Issue 84
Material erosion 80
Electro-magnetic interference (EMI) 80
Contamination during use 80
Loose or intermittent connection 77
Failure to deliver 75
Device inoperable 70
Device Issue 69
Use of Device Issue 63
Stretched 57
Kinked 48
Device alarm system issue 45
Pacing intermittently 44
Electrode(s), fracture of 43
Difficult to advance 43
Installation-related problem 42
Failure to fire 41
Collapse 40
Premature deployment 36
Device expiration issue 35
Replace 33
Total Device Problems 98720

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 2 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Greatbatch Medical II Nov-02-2010
2 Greatbatch Medical II Dec-29-2009
3 Medtronic Inc. Cardiac Rhythm Disease Management II Oct-05-2015
4 Medtronic Inc. Cardiac Rhythm Disease Managment II Mar-23-2010
5 Oscor, Inc. II Sep-24-2008

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