• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 1

Device Problems
Premature discharge of battery 2990
Low battery 2669
Pacer found in back-up mode 1941
Failure to pace or properly pace 1867
Failure to interrogate 1645
Unknown (for use when the device problem is not known) 1364
Failure to capture 1223
Difficult to interrogate 1166
No device output 1119
Oversensing 978
No code available 818
High impedance 748
Normal 727
Premature elective replacement indicator 706
Device displays error message 682
Device remains activated 642
Reset issue 585
Device operates differently than expected 582
No Known Device Problem 578
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 368
Mechanical issue 345
Magnet mode discrepancy 313
Power source issue 298
Connection error 276
Program, failure to 218
No Information 218
Communication or transmission issue 209
Undersensing 196
High sensing threshold 179
Unable to obtain readings 175
Measurements, inaccurate 173
Failure to sense 170
Computer software issue 168
Loss of threshold 167
Connection issue 167
Defective item 157
Intermittent capture 154
Device damaged prior to use 149
Low impedance 142
Electro-magnetic interference (EMI) 139
No display or display failure 137
Failure to power-up 137
Alarm, error of warning 131
Device sensing issue 126
Shock counters, resetting of 125
Artifact 119
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 86
Pocket stimulation 78
False reading from device non-compliance 75
Sensitivity 70
Data Issue 69
Electrical issue 67
Capturing issue 63
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
Crack 47
Product quality issue 44
Break 43
High capture threshold 43
Contamination during use 41
Loss of power 39
Material erosion 38
Inappropriate shock 37
Loss of Data 35
Low readings 35
Incorrect display 33
Device contamination with blood or blood product 30
Migration of device or device component 29
Failure to fire 28
Dislodged or dislocated 27
Dislodged 27
Lead(s), fracture of 27
Output above specifications 23
Programming issue 22
Battery issue 21
Interference 21
Difficult to insert 21
Use of Device Issue 20
Total Device Problems 33939

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

-
-