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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 9

Device Problems
Low battery 3733
Premature discharge of battery 3598
Oversensing 2656
High impedance 2205
No Known Device Problem 1992
Premature elective replacement indicator 1470
Failure to pace or properly pace 1467
Unknown (for use when the device problem is not known) 1331
No code available 1306
Normal 1263
Inappropriate shock 1092
Failure to capture 1071
No Information 1043
Device operates differently than expected 817
Device sensing issue 742
Malfunction 702
Noise 666
Mechanical issue 604
Device displays error message 562
Dislodged or dislocated 529
Connection issue 508
Low impedance 432
Device remains activated 379
Failure to interrogate 375
Undersensing 302
Alarm, error of warning 284
Failure to shock or properly shock 266
Loose or intermittent connection 263
Device alarm system issue 262
High sensing threshold 248
Capturing issue 247
Impedance issue 231
Communication or transmission issue 212
Connection error 178
Other (for use when an appropriate device code cannot be identified) 177
Inappropriate or unexpected reset 167
Material integrity issue 165
Defective item 164
Loss of threshold 164
Pocket stimulation 163
Fracture 161
Ambient noise issue 161
Difficult to interrogate 149
Invalid sensing 149
Artifact 143
Reset issue 143
Failure to convert rhythm 129
Electrical issue 128
High capture threshold 118
Pacer found in back-up mode 111
Delayed charge time 110
Battery issue 104
Use of Device Issue 104
Difficult to insert 104
Electro-magnetic interference (EMI) 94
Migration of device or device component 91
Misconnection 91
Pacing inadequately 89
Protective measure issue 84
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 65
Incorrect measurement 59
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
Intermittent capture 43
Device contamination with blood or blood product 43
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 32
Sensing intermittently 32
Out-of-box failure 32
Failure to charge 28
Installation-related problem 27
Device Issue 26
Product quality issue 26
Contamination during use 25
Implant, repositioning of 24
Output, high 23
Break 22
Incorrect display 19
Low audible alarm 18
Nonstandard device or device component 17
Total Device Problems 38116

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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