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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
53 62 43 51 50 83 50 76 49 27

Device Problems
Low battery 3732
Premature discharge of battery 2659
Oversensing 2471
High impedance 1911
No Known Device Problem 1601
Premature elective replacement indicator 1454
Unknown (for use when the device problem is not known) 1331
Failure to pace or properly pace 1325
No code available 1276
Normal 1262
No Information 1027
Inappropriate shock 968
Failure to capture 941
Device operates differently than expected 753
Device sensing issue 704
Malfunction 702
Noise 666
Device displays error message 510
Dislodged or dislocated 479
Connection issue 466
Mechanical issue 449
Low impedance 413
Device remains activated 379
Failure to interrogate 324
Undersensing 291
Alarm, error of warning 284
Loose or intermittent connection 252
High sensing threshold 248
Device alarm system issue 234
Failure to shock or properly shock 233
Impedance issue 200
Communication or transmission issue 196
Connection error 178
Other (for use when an appropriate device code cannot be identified) 177
Loss of threshold 164
Defective item 163
Inappropriate or unexpected reset 158
Difficult to interrogate 148
Material integrity issue 146
Pocket stimulation 145
Reset issue 138
Artifact 133
Capturing issue 132
Failure to convert rhythm 122
High capture threshold 112
Fracture 105
Difficult to insert 104
Pacer found in back-up mode 102
Delayed charge time 98
Pacing inadequately 88
Use of Device Issue 86
Electro-magnetic interference (EMI) 82
Data Issue 81
Power source issue 79
Failure to deliver 76
Electrical issue 74
Dislodged 74
Protective measure issue 71
Migration of device or device component 71
Premature end-of-life indicator 66
Ambient noise issue 64
Failure to sense 62
Battery issue 62
Output above specifications 58
Interference 55
No device output 54
Material erosion 53
Unable to obtain readings 51
Device damaged prior to use 50
Explanted 47
Incorrect measurement 46
Unexpected therapeutic results 46
Shock counters, resetting of 46
Output issue 46
Telemetry discrepancy 45
Performance 45
Invalid sensing 41
Device contamination with blood or blood product 40
False reading from device non-compliance 40
Intermittent capture 40
Sensitivity 39
Difficult to Program or Calibrate 39
Low readings 38
Device remains implanted 37
Misconnection 34
Out-of-box failure 32
Sensing intermittently 32
Fitting problem 27
Installation-related problem 27
Device Issue 26
Product quality issue 26
Contamination during use 25
Difficult to remove 25
Implant, repositioning of 24
Failure to charge 23
Output, high 23
Break 21
Low audible alarm 18
Nonstandard device or device component 17
Incorrect display 17
Total Device Problems 34455

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 0 2 3 0 1 0 0 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 May-08-2010
2 Boston Scientific CRM Corp II Jul-11-2007
3 Medtronic Inc. Cardiac Rhythm Disease Managment II Oct-21-2010
4 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-09-2009
5 Medtronic Inc. Cardiac Rhythm Managment II Jan-28-2009
6 St Jude Medical CRMD II May-03-2012
7 ela Medical Llc II Sep-27-2010

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