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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 21

Device Problems
Premature discharge of battery 3089
Low battery 2668
Pacer found in back-up mode 1949
Failure to pace or properly pace 1897
Failure to interrogate 1668
Unknown (for use when the device problem is not known) 1362
Failure to capture 1260
Difficult to interrogate 1165
No device output 1120
Oversensing 1049
No code available 850
High impedance 796
Normal 724
Premature elective replacement indicator 710
Device displays error message 697
No Known Device Problem 681
Device remains activated 641
Device operates differently than expected 602
Reset issue 594
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
Pacing inadequately 371
Mechanical issue 364
Magnet mode discrepancy 313
Power source issue 299
Connection error 275
No Information 219
Program, failure to 218
Communication or transmission issue 215
Undersensing 212
Failure to sense 183
Unable to obtain readings 180
High sensing threshold 179
Connection issue 179
Measurements, inaccurate 173
Computer software issue 168
Loss of threshold 167
Low impedance 164
Intermittent capture 161
Defective item 157
Device damaged prior to use 149
Device sensing issue 141
Electro-magnetic interference (EMI) 141
Failure to power-up 138
No display or display failure 137
Artifact 136
Alarm, error of warning 131
Shock counters, resetting of 125
Device remains implanted 118
Premature end-of-life indicator 116
Performance 114
Sensing intermittently 111
Output issue 110
Impedance issue 105
Elective replacement 102
Pacing intermittently 93
Capturing issue 93
Loose or intermittent connection 91
Failure to deliver 89
Dislodged or dislocated 88
High capture threshold 87
Inappropriate shock 81
Pocket stimulation 79
False reading from device non-compliance 74
Electrical issue 71
Sensitivity 70
No pacing 70
Data Issue 70
Break 67
Fracture 62
Invalid sensing 61
Device Issue 61
Difficult to Program or Calibrate 52
Device inoperable 51
Power calculation error due to software problem 50
Out-of-box failure 49
Implant, reprogramming of 48
Crack 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 32
Device contamination with blood or blood product 30
Material integrity issue 30
Failure to fire 28
Battery issue 27
Lead(s), fracture of 27
Dislodged 27
Output above specifications 23
Difficult to insert 22
Programming issue 22
Total Device Problems 34895

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 0
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

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