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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implantable pulse generator, pacemaker (non-crt)
Definition These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Product CodeLWP
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
58 87 78 66 91 123 116 126 97 97 56

Device Problems
Device displays error message 3579
Premature discharge of battery 3453
High impedance 2850
No Known Device Problem 2803
Oversensing 1518
Device operates differently than expected 1347
Failure to pace or properly pace 1322
Ambient noise issue 1320
Failure to capture 1189
Device alarm system issue 963
Capturing issue 693
Low impedance 605
Pacer found in back-up mode 580
Device sensing issue 448
Connection issue 435
No code available 394
Dislodged or dislocated 322
Normal 298
Device damaged prior to use 282
Inappropriate shock 267
Impedance issue 259
Communication or transmission issue 228
High capture threshold 216
Failure to interrogate 198
Electrical issue 187
Undersensing 177
Dislodged 175
Use of Device Issue 174
Output issue 172
Material integrity issue 163
Mechanical issue 160
Pocket stimulation 158
High sensing threshold 152
No device output 126
No display or display failure 120
Fracture 110
Failure to shock or properly shock 105
Loss of threshold 104
Telemetry discrepancy 92
Power source issue 90
Reset issue 88
Fitting problem 84
Unknown (for use when the device problem is not known) 83
Premature elective replacement indicator 74
Positioning Issue 71
Inappropriate or unexpected reset 71
No Information 70
Break 66
Migration of device or device component 65
Failure to sense 60
Difficult to position 57
Battery issue 50
Foreign material present in device 47
Loose or intermittent connection 40
Nonstandard device or device component 38
Noise 35
Intermittent capture 33
Premature end-of-life indicator 31
Other (for use when an appropriate device code cannot be identified) 31
Difficult to remove 31
Not audible alarm 29
Low battery 28
Failure to convert rhythm 27
Incorrect measurement 27
Difficult to interrogate 26
Sensing intermittently 25
Unable to obtain readings 25
Artifact 24
Performance 22
Pacing inadequately 22
Programming issue 22
Difficult to insert 21
Electro-magnetic interference (EMI) 21
Contamination during use 21
Human-Device Interface Issue 20
Failure to power-up 19
Connection error 17
Device Contamination with biological material 17
No pacing 17
Protective measure issue 16
Degraded 16
Lead(s), fracture of 14
Battery impedance issue 13
Out-of-box failure 13
Malfunction 12
Pacing intermittently 12
Material erosion 12
Device contamination with blood or blood product 11
Low readings 11
Unstable capture threshold 11
Missing test results 10
Improper alarm 10
High battery impedance 9
Crack 9
Data Issue 8
Device or device component damaged by another device 7
Material perforation 7
Device remains activated 6
Component missing 6
Calibration issue 6
Total Device Problems 29608

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 1 3 4 0 0 1 2 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific CRM Corp II Oct-18-2014
2 Boston Scientific CRM Corp II Oct-17-2013
3 Boston Scientific CRM Corp II Oct-07-2010
4 Boston Scientific CRM Corp II May-08-2010
5 Boston Scientific CRM Corp II Jan-13-2010
6 Boston Scientific CRM Corp II Aug-18-2009
7 Boston Scientific CRM Corp II Jul-17-2009
8 Boston Scientific CRM Corp II Jul-14-2009
9 Boston Scientific CRM Corp II Aug-21-2008
10 Boston Scientific CRM Corp II Nov-24-2007
11 Boston Scientific Corporation II Dec-30-2016
12 Boston Scientific Corporation II Sep-07-2016
13 Medtronic Inc. Cardiac Rhythm Disease Management II May-24-2014
14 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-22-2010

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