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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 25

Device Problems
Premature discharge of battery 3796
Low battery 3733
Oversensing 2656
High impedance 2175
No Known Device Problem 2015
Failure to pace or properly pace 1486
Premature elective replacement indicator 1472
Unknown (for use when the device problem is not known) 1331
No code available 1306
Normal 1263
Inappropriate shock 1104
Failure to capture 1060
No Information 1044
Device operates differently than expected 812
Device sensing issue 729
Malfunction 702
Noise 664
Mechanical issue 633
Device displays error message 554
Dislodged or dislocated 529
Connection issue 504
Low impedance 428
Failure to interrogate 380
Device remains activated 379
Undersensing 301
Alarm, error of warning 284
Failure to shock or properly shock 273
Loose or intermittent connection 263
Device alarm system issue 260
High sensing threshold 247
Capturing issue 241
Impedance issue 235
Communication or transmission issue 210
Connection error 177
Other (for use when an appropriate device code cannot be identified) 177
Invalid sensing 168
Inappropriate or unexpected reset 168
Material integrity issue 165
Defective item 164
Pocket stimulation 163
Loss of threshold 162
Fracture 162
Electrical issue 158
Ambient noise issue 158
Difficult to interrogate 149
Reset issue 145
Artifact 143
Failure to convert rhythm 130
High capture threshold 119
Delayed charge time 115
Pacer found in back-up mode 114
Battery issue 110
Misconnection 107
Difficult to insert 104
Use of Device Issue 104
Electro-magnetic interference (EMI) 95
Migration of device or device component 92
Pacing inadequately 89
Protective measure issue 87
Data Issue 82
Premature end-of-life indicator 80
Power source issue 79
Failure to deliver 76
Dislodged 74
Failure to sense 68
Unable to obtain readings 66
Incorrect measurement 61
Output above specifications 58
Output issue 57
Interference 55
No device output 55
Material erosion 53
Device damaged prior to use 51
Explanted 48
Unexpected therapeutic results 47
Shock counters, resetting of 46
Telemetry discrepancy 45
Performance 45
Fitting problem 44
Device contamination with blood or blood product 43
Intermittent capture 42
False reading from device non-compliance 40
Sensitivity 39
Difficult to Program or Calibrate 39
Low readings 38
Device remains implanted 37
Difficult to remove 33
Out-of-box failure 32
Failure to charge 32
Sensing intermittently 31
Installation-related problem 27
Device Issue 26
Product quality issue 26
Contamination during use 25
Implant, repositioning of 24
Output, high 23
Break 22
Low audible alarm 19
Incorrect display 19
False alarm 18
Total Device Problems 38419

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 1 0
Class II 1 0 2 3 0 1 0 0 0 0 1
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 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 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-07-2017
7 St Jude Medical CRMD II May-03-2012
8 St Jude Medical Inc. I Oct-21-2016
9 ela Medical Llc II Sep-27-2010

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