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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
0 0 0 0 0 0 0 0 0 6

Device Problems
Premature discharge of battery 3008
Low battery 2669
Pacer found in back-up mode 1941
Failure to pace or properly pace 1872
Failure to interrogate 1648
Unknown (for use when the device problem is not known) 1364
Failure to capture 1228
Difficult to interrogate 1166
No device output 1119
Oversensing 985
No code available 823
High impedance 752
Normal 727
Premature elective replacement indicator 707
Device displays error message 682
Device remains activated 642
No Known Device Problem 590
Reset issue 587
Device operates differently than expected 583
Incorrect measurement 515
Other (for use when an appropriate device code cannot be identified) 501
Malfunction 489
High battery impedance 462
Noise 412
Explanted 392
Telemetry discrepancy 382
Pacing inadequately 369
Mechanical issue 346
Magnet mode discrepancy 313
Power source issue 298
Connection error 276
No Information 219
Program, failure to 218
Communication or transmission issue 209
Undersensing 198
High sensing threshold 179
Unable to obtain readings 176
Failure to sense 173
Measurements, inaccurate 173
Computer software issue 168
Connection issue 168
Loss of threshold 167
Defective item 157
Intermittent capture 155
Device damaged prior to use 149
Low impedance 144
Electro-magnetic interference (EMI) 139
No display or display failure 137
Failure to power-up 137
Alarm, error of warning 131
Device sensing issue 129
Shock counters, resetting of 125
Artifact 124
Device remains implanted 118
Premature end-of-life indicator 117
Performance 114
Sensing intermittently 111
Output issue 107
Elective replacement 102
Pacing intermittently 91
Loose or intermittent connection 90
Failure to deliver 89
Impedance issue 87
Pocket stimulation 78
False reading from device non-compliance 75
Sensitivity 70
Data Issue 69
Electrical issue 67
Capturing issue 64
No pacing 62
Device Issue 61
Difficult to Program or Calibrate 52
Device inoperable 51
Power calculation error due to software problem 50
Invalid sensing 49
Out-of-box failure 49
Implant, reprogramming of 48
High capture threshold 47
Crack 47
Break 45
Product quality issue 44
Inappropriate shock 41
Contamination during use 41
Loss of power 39
Material erosion 38
Loss of Data 35
Low readings 35
Dislodged or dislocated 34
Incorrect display 33
Migration of device or device component 31
Device contamination with blood or blood product 30
Failure to fire 28
Dislodged 27
Lead(s), fracture of 27
Output above specifications 23
Battery issue 22
Programming issue 22
Material integrity issue 21
Interference 21
Difficult to insert 21
Total Device Problems 34046

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