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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implantable pacemaker pulse-generator
Regulation Description Implantable pacemaker pulse generator.
Product CodeDXY
Regulation Number 870.3610
Device Class 3


Premarket Reviews
ManufacturerDecision
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOTRONIK GMBG & CO.
  1
  SE - POSTMARKET SURVEILLANCE REQUIRED 2
  SUBSTANTIALLY EQUIVALENT 6
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 21
ELA MEDICAL, INC.
  2
  SUBSTANTIALLY EQUIVALENT 20
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 37
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 52
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  4
  SUBSTANTIALLY EQUIVALENT 55
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 15
TELECTRONICS
  SUBSTANTIALLY EQUIVALENT 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 0 15 48

Device Problems
Premature discharge of battery 3106
Low battery 2668
Pacer found in back-up mode 1953
Failure to pace or properly pace 1907
Failure to interrogate 1673
Unknown (for use when the device problem is not known) 1362
Failure to capture 1306
Difficult to interrogate 1165
No device output 1120
Oversensing 1096
No code available 864
High impedance 813
No Known Device Problem 776
Normal 724
Premature elective replacement indicator 711
Device displays error message 698
Device remains activated 641
Device operates differently than expected 616
Reset issue 595
Incorrect measurement 522
Other (for use when an appropriate device code cannot be identified) 501
Malfunction 487
High battery impedance 465
Noise 410
Explanted 391
Telemetry discrepancy 383
Mechanical issue 376
Pacing inadequately 375
Magnet mode discrepancy 313
Power source issue 299
Connection error 275
Undersensing 228
No Information 220
Program, failure to 218
Communication or transmission issue 217
Failure to sense 202
Dislodged or dislocated 183
Connection issue 181
Unable to obtain readings 180
High sensing threshold 179
Low impedance 176
Measurements, inaccurate 173
Computer software issue 168
Intermittent capture 167
Loss of threshold 167
Device sensing issue 158
Defective item 157
Artifact 151
Device damaged prior to use 149
Electro-magnetic interference (EMI) 142
Failure to power-up 138
No display or display failure 137
Alarm, error of warning 131
Shock counters, resetting of 125
High capture threshold 125
Device remains implanted 118
Premature end-of-life indicator 116
Performance 114
Output issue 113
Capturing issue 111
Sensing intermittently 111
Impedance issue 110
Elective replacement 102
Pacing intermittently 94
Loose or intermittent connection 91
Failure to deliver 89
Inappropriate shock 87
Break 86
Pocket stimulation 80
Fracture 78
False reading from device non-compliance 74
Electrical issue 72
Data Issue 72
No pacing 72
Sensitivity 70
Invalid sensing 62
Device Issue 61
Difficult to Program or Calibrate 52
Device inoperable 51
Power calculation error due to software problem 50
Crack 49
Out-of-box failure 49
Implant, reprogramming of 48
Product quality issue 45
Contamination during use 41
Loss of power 39
Material erosion 38
Loss of Data 37
Incorrect display 36
Low readings 34
Migration of device or device component 33
Device contamination with blood or blood product 32
Material integrity issue 31
Battery issue 30
Failure to fire 28
Lead(s), fracture of 27
Dislodged 27
Difficult to insert 23
Output above specifications 23
Ambient noise issue 23
Total Device Problems 35492

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

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. Cardiac Rhythm Disease Managment II Apr-26-2010
2 Medtronic Inc. Cardiac Rhythm Disease Managment I Jun-11-2009
3 St Jude Medical CRMD II Jan-11-2012
4 St Jude Medical Inc. II Nov-21-2017

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