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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 12

Device Problems
Device displays error message 3019
Premature discharge of battery 2866
High impedance 2510
No Known Device Problem 2303
Oversensing 1214
Failure to pace or properly pace 1141
Ambient noise issue 1108
Device operates differently than expected 1094
Failure to capture 1032
Device alarm system issue 834
Capturing issue 591
Low impedance 528
Pacer found in back-up mode 427
Device sensing issue 413
No code available 373
Connection issue 334
Normal 298
Device damaged prior to use 282
Dislodged or dislocated 272
Inappropriate shock 240
Impedance issue 221
Communication or transmission issue 193
Dislodged 175
Failure to interrogate 168
High capture threshold 153
High sensing threshold 152
Electrical issue 150
Undersensing 149
Material integrity issue 147
Use of Device Issue 144
Output issue 140
Pocket stimulation 136
Mechanical issue 121
Loss of threshold 104
No device output 99
Fracture 99
Failure to shock or properly shock 94
Unknown (for use when the device problem is not known) 83
No display or display failure 79
Fitting problem 76
Reset issue 73
No Information 68
Power source issue 67
Positioning Issue 65
Telemetry discrepancy 65
Failure to sense 55
Premature elective replacement indicator 55
Difficult to position 53
Migration of device or device component 52
Break 39
Nonstandard device or device component 38
Battery issue 38
Noise 36
Loose or intermittent connection 32
Other (for use when an appropriate device code cannot be identified) 31
Premature end-of-life indicator 29
Intermittent capture 28
Difficult to remove 27
Inappropriate or unexpected reset 27
Low battery 26
Not audible alarm 26
Failure to convert rhythm 24
Sensing intermittently 24
Unable to obtain readings 22
Performance 22
Incorrect measurement 21
Difficult to interrogate 20
Difficult to insert 20
Electro-magnetic interference (EMI) 20
Human-Device Interface Issue 20
Foreign material present in device 20
Connection error 17
Contamination during use 17
Failure to power-up 17
Protective measure issue 17
Lead(s), fracture of 14
Device Contamination with biological material 14
Pacing inadequately 13
Artifact 12
Degraded 12
Material erosion 12
Out-of-box failure 12
Malfunction 12
Device contamination with blood or blood product 11
Low readings 11
Battery impedance issue 11
Improper alarm 10
Missing test results 8
Unstable capture threshold 8
No pacing 7
Programming issue 7
Device or device component damaged by another device 7
Material perforation 7
Failure to deliver 6
Defective item 6
Crack 6
Pacing intermittently 6
Device remains activated 6
Device handling issue 6
Data Issue 5
Total Device Problems 25002

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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