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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 66

Device Problems
Device displays error message 1955
Premature discharge of battery 1910
High impedance 1885
No Known Device Problem 1614
Failure to pace or properly pace 812
Oversensing 804
Failure to capture 798
Device operates differently than expected 769
Ambient noise issue 710
Device alarm system issue 557
Pacer found in back-up mode 427
Capturing issue 384
Low impedance 383
No code available 356
Device sensing issue 342
Normal 297
Device damaged prior to use 282
Connection issue 224
Dislodged or dislocated 194
Dislodged 175
Inappropriate shock 172
Failure to interrogate 165
Impedance issue 160
High sensing threshold 152
Communication or transmission issue 130
Electrical issue 120
Output issue 117
High capture threshold 106
Material integrity issue 102
Loss of threshold 101
Pocket stimulation 99
Mechanical issue 96
Use of Device Issue 96
Undersensing 92
No device output 89
Unknown (for use when the device problem is not known) 80
Fracture 77
Failure to shock or properly shock 71
No Information 68
Telemetry discrepancy 65
Positioning Issue 65
Premature elective replacement indicator 55
No display or display failure 54
Reset issue 54
Failure to sense 48
Power source issue 47
Fitting problem 46
Difficult to position 45
Nonstandard device or device component 38
Migration of device or device component 32
Break 32
Battery issue 32
Other (for use when an appropriate device code cannot be identified) 31
Noise 30
Premature end-of-life indicator 29
Difficult to remove 25
Intermittent capture 25
Sensing intermittently 24
Low battery 24
Performance 22
Loose or intermittent connection 21
Electro-magnetic interference (EMI) 20
Not audible alarm 19
Difficult to insert 19
Difficult to interrogate 19
Failure to convert rhythm 19
Unable to obtain readings 19
Incorrect measurement 18
Protective measure issue 16
Contamination during use 15
Connection error 14
Lead(s), fracture of 14
Failure to power-up 14
Inappropriate or unexpected reset 14
Pacing inadequately 13
Material erosion 12
Human-Device Interface Issue 12
Out-of-box failure 12
Foreign material present in device 11
Battery impedance issue 11
Device contamination with blood or blood product 10
Malfunction 10
Artifact 10
Degraded 9
Low readings 9
Material perforation 7
Device or device component damaged by another device 7
Programming issue 7
No pacing 7
Device Contamination with biological material 6
Failure to deliver 6
Defective item 6
Device remains activated 6
Pacing intermittently 5
Sensitivity 5
Deployment issue 5
Disinfection or Sterilization Issue at User Location 5
Improper alarm 5
Unstable capture threshold 5
Missing test results 5
Total Device Problems 18241

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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