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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 8940
Failure to capture 8168
Dislodged or dislocated 5897
Oversensing 5379
Low impedance 4734
High sensing threshold 4502
No Known Device Problem 4363
Dislodged 3760
High capture threshold 3415
Capturing issue 3381
Fracture 2866
No code available 2628
Undersensing 2450
Device damaged prior to use 2434
Normal 2307
Difficult to position 2127
Impedance issue 2008
Failure to pace or properly pace 1801
Artifact 1643
Noise 1485
Failure to sense 1370
Device sensing issue 1337
Device remains activated 1320
Loss of threshold 1208
Intermittent capture 1082
Explanted 1021
Lead(s), fracture of 952
No Information 853
Unknown (for use when the device problem is not known) 845
Retraction problem 832
Failure to deploy 777
Failure to advance 737
Device remains implanted 727
Pocket stimulation 722
Patient-device incompatibility 669
Material integrity issue 653
Break 576
Other (for use when an appropriate device code cannot be identified) 531
Ambient noise issue 517
Deployment issue 514
Mechanical issue 488
Positioning Issue 486
Defective item 482
Sensing intermittently 461
Degraded 445
Unstable capture threshold 382
Implant, reprogramming of 363
Implant, repositioning of 339
Invalid sensing 322
Low sensing threshold 318
Inappropriate shock 315
Device operates differently than expected 312
Decreased sensitivity 267
Insulation, hole(s) in 244
Difficult to remove 243
Sensitivity 241
Difficult to insert 240
Insulation degradation 210
Connection error 203
Performance 200
Low readings 196
Cut in material 191
Connection issue 191
Material perforation 178
Difficult to deploy 165
Interference 162
Malfunction 160
Bent 142
Electronic property issue 130
Application interface becomes non-functional or program exits abnormally 125
Electrical issue 116
Size incorrect for patient 112
No pacing 111
Device contamination with blood or blood product 109
Hole in material 108
Pacing inadequately 107
Crack 103
Insulation failure 92
Human-Device Interface Issue 86
Migration of device or device component 83
Electro-magnetic interference (EMI) 82
Material erosion 80
Contamination during use 80
Loose or intermittent connection 77
Failure to deliver 75
Device inoperable 70
Device Issue 69
Use of Device Issue 62
Stretched 57
Kinked 52
Device alarm system issue 45
Collapse 44
Pacing intermittently 44
Premature deployment 44
Electrode(s), fracture of 43
Difficult to advance 43
Installation-related problem 42
Failure to fire 41
Device expiration issue 38
Replace 33
Total Device Problems 101880

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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