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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 11

Device Problems
Premature discharge of battery 3060
Low battery 2668
Pacer found in back-up mode 1944
Failure to pace or properly pace 1890
Failure to interrogate 1660
Unknown (for use when the device problem is not known) 1362
Failure to capture 1245
Difficult to interrogate 1165
No device output 1120
Oversensing 1023
No code available 845
High impedance 779
Normal 724
Premature elective replacement indicator 708
Device displays error message 695
Device remains activated 641
No Known Device Problem 636
Device operates differently than expected 597
Reset issue 590
Incorrect measurement 521
Other (for use when an appropriate device code cannot be identified) 501
Malfunction 487
High battery impedance 464
Noise 410
Explanted 391
Telemetry discrepancy 382
Pacing inadequately 370
Mechanical issue 354
Magnet mode discrepancy 313
Power source issue 298
Connection error 275
No Information 219
Program, failure to 218
Communication or transmission issue 213
Undersensing 209
High sensing threshold 179
Unable to obtain readings 176
Failure to sense 174
Measurements, inaccurate 173
Connection issue 173
Computer software issue 168
Loss of threshold 167
Defective item 157
Intermittent capture 156
Low impedance 155
Device damaged prior to use 149
Electro-magnetic interference (EMI) 140
Failure to power-up 138
No display or display failure 137
Device sensing issue 133
Artifact 132
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 109
Elective replacement 102
Impedance issue 98
Loose or intermittent connection 91
Pacing intermittently 91
Failure to deliver 89
Capturing issue 84
Pocket stimulation 79
False reading from device non-compliance 74
High capture threshold 72
Data Issue 70
Sensitivity 70
Inappropriate shock 68
Electrical issue 68
No pacing 65
Device Issue 61
Invalid sensing 56
Dislodged or dislocated 56
Break 56
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
Fracture 48
Crack 47
Product quality issue 44
Contamination during use 41
Loss of power 39
Material erosion 38
Loss of Data 36
Low readings 34
Incorrect display 34
Migration of device or device component 31
Device contamination with blood or blood product 30
Failure to fire 28
Material integrity issue 28
Lead(s), fracture of 27
Dislodged 27
Battery issue 25
Output above specifications 23
Programming issue 22
Interference 21
Total Device Problems 34531

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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