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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
57 87 78 66 88 121 36

Device Problems
High impedance 511
Failure to capture 300
Normal 296
Device damaged prior to use 287
No code available 250
Dislodged 176
High sensing threshold 148
Loss of threshold 100
No Known Device Problem 91
Failure to interrogate 77
Pacer found in back-up mode 62
Unknown (for use when the device problem is not known) 58
Failure to pace or properly pace 57
Pocket stimulation 57
Device sensing issue 40
Difficult to position 40
Fracture 36
Reset issue 33
Premature elective replacement indicator 32
Other (for use when an appropriate device code cannot be identified) 29
No Information 28
Telemetry discrepancy 28
Premature end-of-life indicator 25
Premature discharge of battery 23
Oversensing 23
No device output 22
Performance 20
Mechanical issue 18
Electro-magnetic interference (EMI) 17
Sensing intermittently 16
Failure to sense 15
Lead(s), fracture of 15
Output issue 14
Noise 14
Dislodged or dislocated 13
Intermittent capture 13
Unable to obtain readings 13
Material erosion 12
Use of Device Issue 12
Connection error 11
Low battery 11
Material integrity issue 11
Low impedance 10
Difficult to interrogate 10
Capturing issue 10
Incorrect measurement 9
Low readings 9
Difficult to remove 9
Undersensing 8
Communication or transmission issue 8
Out-of-box failure 7
Material perforation 7
Failure to deliver 6
Break 6
Device displays error message 6
Device remains activated 6
No pacing 5
Artifact 5
Defective item 5
Sensitivity 5
Insulation, hole(s) in 4
Programming issue 4
Insulation degradation 4
Impedance issue 4
Difficult to insert 4
Loose or intermittent connection 3
Measurements, inaccurate 3
Connection issue 3
Malfunction 3
Component(s), broken 3
Electrode(s), migration of 3
Pacing inadequately 3
Device contamination with blood or blood product 3
Power source issue 3
Battery issue 3
Data Issue 3
Inappropriate shock 3
Unexpected therapeutic results 2
Device inoperable 2
Program, failure to 2
Contamination during use 2
Failure to advance 2
Pacing intermittently 2
Migration of device or device component 2
Patient-device incompatibility 2
Device or device fragments location unknown 2
Battery impedance issue 2
Computer software issue 2
Electrical issue 2
Shock counters, resetting of 2
Output above specifications 1
Battery failure 1
Material frayed 1
Low sensing threshold 1
Device disinfection or sterilization issue 1
Device expiration issue 1
Degraded 1
Incorrect display 1
Retraction problem 1
Device clogged 1
Total Device Problems 3277

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 1 3 4 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific CRM Corp II Oct-07-2010
2 Boston Scientific CRM Corp II May-08-2010
3 Boston Scientific CRM Corp II Jan-13-2010
4 Boston Scientific CRM Corp II Aug-18-2009
5 Boston Scientific CRM Corp II Jul-17-2009
6 Boston Scientific CRM Corp II Jul-14-2009
7 Boston Scientific CRM Corp II Aug-21-2008
8 Boston Scientific CRM Corp II Nov-24-2007
9 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-22-2010

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