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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 17

Device Problems
High impedance 1547
Device displays error message 1440
Premature discharge of battery 1434
No Known Device Problem 1061
Failure to capture 646
Device operates differently than expected 599
Failure to pace or properly pace 595
Oversensing 580
Ambient noise issue 474
Pacer found in back-up mode 426
Device alarm system issue 420
No code available 335
Low impedance 305
Normal 297
Device sensing issue 286
Device damaged prior to use 282
Capturing issue 244
Dislodged 175
Failure to interrogate 162
High sensing threshold 152
Connection issue 150
Dislodged or dislocated 141
Inappropriate shock 130
Impedance issue 121
Loss of threshold 101
Output issue 95
Communication or transmission issue 92
Pocket stimulation 84
No device output 83
Electrical issue 83
Unknown (for use when the device problem is not known) 80
Material integrity issue 79
Use of Device Issue 78
Mechanical issue 72
No Information 67
Undersensing 65
Telemetry discrepancy 65
Positioning Issue 61
Fracture 59
High capture threshold 57
Failure to shock or properly shock 57
Premature elective replacement indicator 55
Reset issue 45
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
Material erosion 12
Protective measure issue 12
Out-of-box failure 12
Battery impedance issue 11
Not audible alarm 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 14178

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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