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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
58 87 78 66 91 123 115 126 97 36

Device Problems
High impedance 1580
Premature discharge of battery 1456
Device displays error message 1451
No Known Device Problem 1084
Failure to capture 657
Device operates differently than expected 614
Failure to pace or properly pace 610
Oversensing 598
Ambient noise issue 497
Pacer found in back-up mode 427
Device alarm system issue 426
No code available 337
Low impedance 315
Normal 297
Device sensing issue 294
Device damaged prior to use 282
Capturing issue 260
Dislodged 175
Failure to interrogate 162
Connection issue 156
High sensing threshold 152
Dislodged or dislocated 143
Inappropriate shock 135
Impedance issue 123
Loss of threshold 101
Communication or transmission issue 95
Output issue 95
Pocket stimulation 84
Electrical issue 84
No device output 83
Use of Device Issue 81
Unknown (for use when the device problem is not known) 80
Material integrity issue 80
Mechanical issue 72
Undersensing 68
No Information 67
Telemetry discrepancy 65
Fracture 62
Positioning Issue 61
High capture threshold 58
Failure to shock or properly shock 58
Premature elective replacement indicator 55
Reset issue 46
Difficult to position 43
Failure to sense 43
Nonstandard device or device component 38
Other (for use when an appropriate device code cannot be identified) 31
Noise 30
Premature end-of-life indicator 29
Difficult to remove 24
Migration of device or device component 24
Low battery 24
Battery issue 24
Sensing intermittently 23
Power source issue 22
Performance 22
Intermittent capture 20
Difficult to insert 19
Electro-magnetic interference (EMI) 19
Difficult to interrogate 19
Loose or intermittent connection 18
No display or display failure 17
Incorrect measurement 16
Failure to convert rhythm 15
Unable to obtain readings 15
Lead(s), fracture of 14
Break 14
Connection error 14
Pacing inadequately 13
Not audible alarm 12
Material erosion 12
Protective measure issue 12
Out-of-box failure 12
Battery impedance issue 11
Device contamination with blood or blood product 10
Malfunction 10
Low readings 9
Fitting problem 7
Material perforation 7
Device or device component damaged by another device 7
Programming issue 7
Artifact 7
Failure to power-up 7
Device remains activated 6
Failure to deliver 6
Defective item 6
No pacing 6
Sensitivity 5
Pacing intermittently 5
Contamination during use 5
Insulation degradation 4
Insulation, hole(s) in 4
Component(s), broken 4
Degraded 4
False reading from device non-compliance 4
Disinfection or Sterilization Issue at User Location 4
Output below specifications 4
Human-Device Interface Issue 4
Data Issue 4
Loss of Data 4
Total Device Problems 14425

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 1 3 4 0 0 1 2 0 0
Class III 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 Medtronic Inc. Cardiac Rhythm Disease Management II May-24-2014
12 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-22-2010

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