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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 91 123 116 126 97 90

Device Problems
Device displays error message 2476
Premature discharge of battery 2358
High impedance 2212
No Known Device Problem 1954
Oversensing 999
Failure to pace or properly pace 987
Device operates differently than expected 933
Ambient noise issue 921
Failure to capture 919
Device alarm system issue 684
Capturing issue 503
Low impedance 464
Pacer found in back-up mode 427
Device sensing issue 381
No code available 365
Normal 297
Device damaged prior to use 282
Connection issue 276
Dislodged or dislocated 231
Inappropriate shock 211
Impedance issue 185
Dislodged 175
Failure to interrogate 168
Communication or transmission issue 158
High sensing threshold 152
Electrical issue 133
Output issue 128
Material integrity issue 127
High capture threshold 126
Pocket stimulation 118
Use of Device Issue 116
Undersensing 110
Mechanical issue 105
Loss of threshold 101
No device output 96
Fracture 92
Failure to shock or properly shock 83
Unknown (for use when the device problem is not known) 80
No Information 68
Telemetry discrepancy 65
Positioning Issue 65
No display or display failure 64
Reset issue 64
Fitting problem 63
Power source issue 60
Premature elective replacement indicator 55
Failure to sense 54
Difficult to position 48
Migration of device or device component 43
Nonstandard device or device component 38
Break 36
Battery issue 34
Other (for use when an appropriate device code cannot be identified) 31
Noise 30
Premature end-of-life indicator 29
Intermittent capture 27
Difficult to remove 26
Loose or intermittent connection 25
Sensing intermittently 24
Low battery 24
Inappropriate or unexpected reset 23
Performance 22
Not audible alarm 21
Failure to convert rhythm 21
Electro-magnetic interference (EMI) 20
Unable to obtain readings 20
Incorrect measurement 20
Difficult to insert 19
Difficult to interrogate 19
Protective measure issue 17
Contamination during use 16
Failure to power-up 15
Human-Device Interface Issue 15
Foreign material present in device 14
Lead(s), fracture of 14
Connection error 14
Pacing inadequately 13
Material erosion 12
Out-of-box failure 12
Battery impedance issue 11
Degraded 11
Artifact 11
Device contamination with blood or blood product 10
Malfunction 10
Low readings 9
Device Contamination with biological material 9
Device or device component damaged by another device 7
Improper alarm 7
Programming issue 7
Material perforation 7
No pacing 7
Unstable capture threshold 7
Missing test results 6
Failure to deliver 6
Defective item 6
Pacing intermittently 6
Device remains activated 6
Crack 5
Sensitivity 5
Deployment issue 5
Total Device Problems 21591

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 1
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 Boston Scientific Corporation II Sep-07-2016
12 Medtronic Inc. Cardiac Rhythm Disease Management II May-24-2014
13 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-22-2010

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