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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 49

Device Problems
Premature discharge of battery 4098
Low battery 3733
No Known Device Problem 3667
Oversensing 3154
High impedance 2286
Failure to pace or properly pace 1544
Premature elective replacement indicator 1493
Unknown (for use when the device problem is not known) 1331
No code available 1312
Normal 1263
Inappropriate shock 1214
Failure to capture 1115
No Information 1046
Device operates differently than expected 875
Device sensing issue 738
Malfunction 702
Noise 664
Mechanical issue 662
Device displays error message 580
Dislodged or dislocated 545
Connection issue 517
Low impedance 441
Failure to interrogate 416
Device remains activated 379
Undersensing 313
Failure to shock or properly shock 286
Alarm, error of warning 284
Capturing issue 271
Device alarm system issue 267
Loose or intermittent connection 266
Impedance issue 250
High sensing threshold 247
Communication or transmission issue 224
Inappropriate or unexpected reset 219
Invalid sensing 212
Electrical issue 207
Ambient noise issue 196
Fracture 185
Connection error 177
Other (for use when an appropriate device code cannot be identified) 177
Material integrity issue 173
Pocket stimulation 170
Defective item 164
Loss of threshold 162
Artifact 155
Difficult to interrogate 153
Reset issue 149
Failure to convert rhythm 134
High capture threshold 131
Delayed charge time 126
Pacer found in back-up mode 125
Battery issue 118
Misconnection 117
Use of Device Issue 108
Difficult to insert 106
Migration of device or device component 101
Electro-magnetic interference (EMI) 98
Protective measure issue 91
Pacing inadequately 90
Data Issue 82
Premature end-of-life indicator 81
Power source issue 79
Failure to deliver 76
Dislodged 74
Failure to sense 71
Output issue 70
Unable to obtain readings 69
Incorrect measurement 65
Output above specifications 58
No device output 56
Interference 55
Material erosion 53
Device damaged prior to use 51
Unexpected therapeutic results 49
Telemetry discrepancy 48
Explanted 48
Intermittent capture 48
Fitting problem 46
Shock counters, resetting of 46
Performance 45
Device contamination with blood or blood product 44
Difficult to remove 41
False reading from device non-compliance 40
Difficult to Program or Calibrate 39
Sensitivity 39
Low readings 38
Device remains implanted 37
Failure to charge 32
Out-of-box failure 32
Sensing intermittently 31
Installation-related problem 27
Device Issue 26
Product quality issue 26
Contamination during use 25
Implant, repositioning of 24
Break 23
Output, high 23
Low audible alarm 19
False alarm 19
Incorrect display 19
Total Device Problems 41901

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 2
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 May-19-2017
7 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-07-2017
8 St Jude Medical CRMD II May-03-2012
9 St Jude Medical Inc. I Oct-21-2016
10 ela Medical Llc II Sep-27-2010

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