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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implantable cardioverter defibrillator (non-crt)
Definition These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Product CodeLWS
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
70 94 80 119 136 129 148 168 100 145 9

Device Problems
Oversensing 13660
High impedance 13269
Inappropriate shock 9740
Low battery 6812
Normal 5367
No Known Device Problem 4521
Fracture 3553
Malfunction 3483
No Information 3098
No code available 3096
Noise 3067
Failure to capture 2910
Lead(s), fracture of 2851
Premature discharge of battery 2723
Failure to pace or properly pace 2706
Device operates differently than expected 2588
Artifact 2492
Low impedance 2385
High sensing threshold 2288
Unknown (for use when the device problem is not known) 2226
Impedance issue 2189
Device sensing issue 2067
Device remains activated 1878
Dislodged 1818
Device displays error message 1816
Premature elective replacement indicator 1797
Dislodged or dislocated 1641
Undersensing 1573
Interference 1326
Defective item 1251
Capturing issue 1226
Device damaged prior to use 1182
Mechanical issue 1112
Ambient noise issue 1015
Difficult to position 1011
Failure to deploy 989
Invalid sensing 988
Failure to advance 987
Loss of threshold 927
High capture threshold 919
Alarm, error of warning 891
Failure to shock or properly shock 846
Retraction problem 838
Device alarm system issue 786
Failure to interrogate 687
Loose or intermittent connection 655
Other (for use when an appropriate device code cannot be identified) 629
Connection issue 626
Explanted 613
Sensitivity 608
Difficult to insert 496
Reset issue 476
Material integrity issue 462
Connection error 446
Failure to convert rhythm 428
Communication or transmission issue 428
Break 403
Low readings 401
Difficult to interrogate 351
Inappropriate or unexpected reset 351
Failure to sense 311
Electro-magnetic interference (EMI) 289
Delayed charge time 275
Intermittent capture 269
Electrical issue 265
Device remains implanted 263
Performance 236
Protective measure issue 226
Device Issue 224
Implant, repositioning of 218
Pocket stimulation 210
Insulation, hole(s) in 207
Pacer found in back-up mode 202
Migration of device or device component 199
Sensing intermittently 198
Low sensing threshold 185
Pacing inadequately 180
Insulation degradation 179
Failure to deliver 178
Device contamination with blood or blood product 170
Patient-device incompatibility 169
No device output 162
Deployment issue 156
Degraded 152
Battery issue 145
Nonstandard device or device component 142
Premature end-of-life indicator 141
Shock counters, resetting of 141
Failure to charge 120
Unexpected therapeutic results 118
Difficult to deploy 116
Decreased sensitivity 109
Bent 108
Difficult to remove 105
Data Issue 104
Output issue 102
Cut in material 99
Positioning Issue 98
Telemetry discrepancy 98
Material erosion 93
Total Device Problems 138930

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 1 0 0 0 0 1 0 0 0 2 0
Class II 0 0 4 3 4 3 3 2 1 2 0
Class III 0 0 1 0 1 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific CRM Corp II Aug-05-2014
2 Boston Scientific CRM Corp II Aug-16-2013
3 Boston Scientific CRM Corp II May-20-2013
4 Boston Scientific CRM Corp II Mar-18-2013
5 Boston Scientific CRM Corp II Apr-20-2012
6 Boston Scientific CRM Corp II Mar-01-2012
7 Boston Scientific CRM Corp III Feb-23-2012
8 Boston Scientific CRM Corp II Dec-01-2011
9 Boston Scientific CRM Corp II Oct-12-2011
10 Boston Scientific CRM Corp III Sep-28-2011
11 Boston Scientific CRM Corp II Sep-09-2011
12 Boston Scientific CRM Corp II Apr-26-2011
13 Boston Scientific CRM Corp II May-20-2010
14 Boston Scientific CRM Corp II Nov-12-2009
15 Boston Scientific Corporation II Nov-06-2015
16 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-22-2012
17 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-26-2010
18 Medtronic Inc. Cardiac Rhythm Disease Managment II Oct-21-2010
19 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-09-2009
20 Medtronic Inc. Cardiac Rhythm Managment II Aug-18-2009
21 Medtronic Inc. Cardiac Rhythm Managment III Apr-08-2009
22 Medtronic Inc. Cardiac Rhythm Managment II Jan-28-2009
23 Medtronic Inc. Cardiac Rhythm Managment I Oct-25-2007
24 Medtronic Inc., Cardiac Rhythm and Heart Failure II Aug-25-2016
25 St Jude Medical CRMD I Jan-11-2012
26 St Jude Medical Cardiac Rhythm Management Division I Jan-21-2016
27 St Jude Medical Cardiac Rhythm Management Division II Sep-03-2014
28 St Jude Medical Inc. I Oct-21-2016
29 St Jude Medical Inc. II May-10-2016

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