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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Definition These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
Product CodeNIK
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
53 62 43 51 50 83 50 76 49 109 94

Device Problems
No Known Device Problem 4988
Premature discharge of battery 4662
Oversensing 4247
Low battery 3734
High impedance 2487
Failure to pace or properly pace 1654
Premature elective replacement indicator 1507
Inappropriate shock 1390
Unknown (for use when the device problem is not known) 1332
No code available 1319
Normal 1263
Failure to capture 1239
No Information 1048
Device operates differently than expected 989
Device sensing issue 759
Mechanical issue 753
Malfunction 702
Noise 664
Device displays error message 627
Dislodged or dislocated 588
Connection issue 542
Low impedance 462
Failure to interrogate 461
Device remains activated 379
Undersensing 355
Capturing issue 341
Inappropriate or unexpected reset 331
Failure to shock or properly shock 330
Invalid sensing 301
Device alarm system issue 289
Alarm, error of warning 284
Battery issue 273
Impedance issue 271
Loose or intermittent connection 269
Electrical issue 269
Ambient noise issue 262
High sensing threshold 247
Communication or transmission issue 238
Fracture 214
Material integrity issue 187
Artifact 185
Pocket stimulation 181
Other (for use when an appropriate device code cannot be identified) 177
Connection error 177
Defective item 164
Loss of threshold 163
Delayed charge time 161
Difficult to interrogate 156
Pacer found in back-up mode 153
Reset issue 151
High capture threshold 150
Failure to convert rhythm 145
Misconnection 143
Migration of device or device component 124
Use of Device Issue 117
Difficult to insert 112
Electro-magnetic interference (EMI) 99
Pacing inadequately 99
Protective measure issue 99
Premature end-of-life indicator 91
Data Issue 87
Output issue 84
Unable to obtain readings 81
Power source issue 79
Incorrect measurement 78
Failure to deliver 76
Dislodged 74
Failure to sense 73
No device output 64
Telemetry discrepancy 59
Output above specifications 58
Difficult to remove 56
Interference 55
Material erosion 53
Intermittent capture 53
Fitting problem 53
Device damaged prior to use 51
Unexpected therapeutic results 50
Explanted 48
Shock counters, resetting of 46
Performance 45
Device contamination with blood or blood product 45
False reading from device non-compliance 40
Failure to charge 39
Difficult to Program or Calibrate 39
Sensitivity 39
Low readings 38
Device remains implanted 37
Sensing intermittently 34
Out-of-box failure 33
Programming issue 29
Installation-related problem 27
Device Issue 26
No pacing 26
Product quality issue 26
Break 25
Contamination during use 25
Implant, repositioning of 24
Output, high 23
Low audible alarm 19
Total Device Problems 47021

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 1 1
Class II 1 0 2 3 0 1 0 0 0 0 4
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 May-08-2010
2 Boston Scientific CRM Corp II Jul-11-2007
3 Boston Scientific Corporation II Nov-08-2017
4 Medtronic Inc. Cardiac Rhythm Disease Managment II Oct-21-2010
5 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-09-2009
6 Medtronic Inc. Cardiac Rhythm Managment II Jan-28-2009
7 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-19-2017
8 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-07-2017
9 Sorin Group Italia SRL - CRF II Sep-28-2017
10 St Jude Medical CRMD II May-03-2012
11 St Jude Medical Inc. I Oct-10-2017
12 St Jude Medical Inc. I Oct-21-2016
13 ela Medical Llc II Sep-27-2010

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