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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 58

Device Problems
Device displays error message 1944
Premature discharge of battery 1892
High impedance 1862
No Known Device Problem 1502
Failure to pace or properly pace 792
Oversensing 786
Failure to capture 784
Device operates differently than expected 749
Ambient noise issue 696
Device alarm system issue 557
Pacer found in back-up mode 427
Low impedance 377
Capturing issue 373
No code available 349
Device sensing issue 336
Normal 297
Device damaged prior to use 282
Connection issue 212
Dislodged or dislocated 184
Dislodged 175
Inappropriate shock 167
Failure to interrogate 164
Impedance issue 159
High sensing threshold 152
Communication or transmission issue 127
Electrical issue 110
Output issue 103
Material integrity issue 102
Loss of threshold 101
Pocket stimulation 98
Use of Device Issue 95
Undersensing 88
Mechanical issue 87
No device output 86
High capture threshold 83
Unknown (for use when the device problem is not known) 80
Fracture 73
Failure to shock or properly shock 71
No Information 67
Telemetry discrepancy 65
Positioning Issue 63
Premature elective replacement indicator 55
Reset issue 50
Failure to sense 47
Difficult to position 45
Fitting problem 44
Nonstandard device or device component 38
No display or display failure 38
Power source issue 34
Migration of device or device component 32
Other (for use when an appropriate device code cannot be identified) 31
Battery issue 31
Noise 30
Premature end-of-life indicator 29
Break 26
Difficult to remove 24
Sensing intermittently 24
Low battery 24
Performance 22
Intermittent capture 22
Electro-magnetic interference (EMI) 20
Loose or intermittent connection 20
Difficult to interrogate 19
Difficult to insert 19
Not audible alarm 19
Failure to convert rhythm 18
Incorrect measurement 17
Protective measure issue 16
Unable to obtain readings 15
Lead(s), fracture of 14
Connection error 14
Pacing inadequately 13
Material erosion 12
Human-Device Interface Issue 12
Out-of-box failure 12
Battery impedance issue 11
Contamination during use 11
Failure to power-up 11
Device contamination with blood or blood product 10
Malfunction 10
Low readings 9
Inappropriate or unexpected reset 9
Artifact 9
Programming issue 7
Device or device component damaged by another device 7
Material perforation 7
Failure to deliver 6
Defective item 6
Device Contamination with biological material 6
Degraded 6
Device remains activated 6
No pacing 6
Sensitivity 5
Pacing intermittently 5
Disinfection or Sterilization Issue at User Location 5
Data Issue 5
Output below specifications 4
Improper alarm 4
Loss of Data 4
Deployment issue 4
Total Device Problems 17776

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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