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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.
  SE SUBJECT TO TRACKING REG 8
  SE SUBJECT TO TRAKING & PMS 4
  SUBSTANTIALLY EQUIVALENT 14
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 13
DIAG CORP.
  SUBSTANTIALLY EQUIVALENT 5
ELA MEDICAL, INC.
  SE SUBJECT TO TRACKING REG 2
  SE SUBJECT TO TRAKING & PMS 1
  SUBSTANTIALLY EQUIVALENT 8
GUIDANT CORP
  SE SUBJECT TO TRAKING & PMS 2
  SUBSTANTIALLY EQUIVALENT 30
  SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE 1
INTERMEDICS
  SE SUBJECT TO TRACKING REG 5
  SE SUBJECT TO TRAKING & PMS 1
  SUBSTANTIALLY EQUIVALENT 97
  SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE 2
MEDTRONIC, INC.
  SE SUBJECT TO TRACKING REG 6
  SE SUBJECT TO TRAKING & PMS 1
  SUBSTANTIALLY EQUIVALENT 58
  SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE 5
OSCOR, INC.
  SE SUBJECT TO TRACKING REG 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 SUBJECT TO TRACKING REG 4
  SUBSTANTIALLY EQUIVALENT 29
  SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE 2
TELECTRONICS
  SE SUBJECT TO TRACKING REG 2
  SUBSTANTIALLY EQUIVALENT 8
VASCOR MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE 1

Device Problems
High impedance 6691
Failure to capture 6287
High sensing threshold 4458
Low impedance 3801
Dislodged 3765
Dislodged or dislocated 3616
Oversensing 3161
Device damaged prior to use 2438
No Known Device Problem 2392
No code available 2322
Normal 2308
Capturing issue 2265
Difficult to position 2081
Fracture 1596
Noise 1486
Impedance issue 1353
Device remains activated 1322
Loss of threshold 1211
Failure to pace or properly pace 1194
Undersensing 1145
Failure to sense 979
High capture threshold 972
Artifact 961
Lead(s), fracture of 953
Explanted 911
Device sensing issue 877
Unknown (for use when the device problem is not known) 847
Retraction problem 816
Intermittent capture 790
Failure to advance 727
Device remains implanted 724
No Information 682
Patient-device incompatibility 666
Pocket stimulation 639
Other (for use when an appropriate device code cannot be identified) 533
Defective item 461
Failure to deploy 441
Sensing intermittently 441
Mechanical issue 432
Degraded 364
Implant, reprogramming of 363
Implant, repositioning of 339
Invalid sensing 315
Low sensing threshold 315
Inappropriate shock 289
Break 254
Insulation, hole(s) in 244
Sensitivity 241
Difficult to insert 221
Insulation degradation 210
Connection error 204
Performance 200
Low readings 197
Material perforation 178
Cut in material 175
Interference 162
Difficult to remove 157
Malfunction 156
Difficult to deploy 152
Application interface becomes non-functional or program exits abnormally 121
Size incorrect for patient 112
Material integrity issue 110
Hole in material 108
Pacing inadequately 99
Decreased sensitivity 96
Crack 94
Insulation failure 92
No pacing 91
Device contamination with blood or blood product 91
Electrical issue 85
Contamination during use 80
Material erosion 79
Failure to deliver 75
Loose or intermittent connection 71
Device inoperable 70
Migration of device or device component 69
Device Issue 69
Electro-magnetic interference (EMI) 67
Bent 63
Stretched 47
Use of Device Issue 45
Connection issue 43
Device alarm system issue 42
Installation-related problem 42
Failure to fire 41
Electrode(s), fracture of 39
Deployment issue 37
Pacing intermittently 37
Unstable capture threshold 36
Replace 33
Kinked 32
Device expiration issue 31
No device output 28
Device or device component damaged by another device 27
Output above specifications 27
Elective replacement 26
Misconnection 26
Device, or device fragments remain in patient 26
Malposition of device 23
Positioning Issue 23
Total Device Problems 75933

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 1 2 0 0 0
Class III 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 Managment II Mar-23-2010
4 Oscor, Inc. II Sep-24-2008

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