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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 7

Device Problems
Premature discharge of battery 3018
Low battery 2669
Pacer found in back-up mode 1941
Failure to pace or properly pace 1879
Failure to interrogate 1651
Unknown (for use when the device problem is not known) 1364
Failure to capture 1233
Difficult to interrogate 1166
No device output 1120
Oversensing 998
No code available 828
High impedance 761
Normal 727
Premature elective replacement indicator 707
Device displays error message 685
Device remains activated 642
No Known Device Problem 604
Reset issue 589
Device operates differently than expected 587
Incorrect measurement 516
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 350
Magnet mode discrepancy 313
Power source issue 298
Connection error 276
No Information 219
Program, failure to 218
Communication or transmission issue 211
Undersensing 200
High sensing threshold 179
Unable to obtain readings 176
Failure to sense 173
Measurements, inaccurate 173
Connection issue 169
Computer software issue 168
Loss of threshold 167
Defective item 157
Intermittent capture 155
Device damaged prior to use 149
Low impedance 147
Electro-magnetic interference (EMI) 140
Failure to power-up 138
No display or display failure 137
Alarm, error of warning 131
Device sensing issue 129
Artifact 126
Shock counters, resetting of 125
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
Impedance issue 89
Failure to deliver 89
Pocket stimulation 78
False reading from device non-compliance 75
Capturing issue 73
Sensitivity 70
Data Issue 69
Electrical issue 68
No pacing 62
Device Issue 61
Difficult to Program or Calibrate 52
Device inoperable 51
Invalid sensing 50
High capture threshold 50
Power calculation error due to software problem 50
Break 50
Inappropriate shock 49
Out-of-box failure 49
Implant, reprogramming of 48
Crack 47
Product quality issue 44
Contamination during use 41
Dislodged or dislocated 41
Loss of power 39
Material erosion 38
Loss of Data 35
Low readings 35
Incorrect display 33
Migration of device or device component 31
Device contamination with blood or blood product 30
Failure to fire 28
Fracture 28
Lead(s), fracture of 27
Dislodged 27
Battery issue 24
Material integrity issue 24
Output above specifications 23
Programming issue 22
Interference 21
Total Device Problems 34187

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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