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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 49 104

Device Problems
Low battery 3733
Premature discharge of battery 3339
Oversensing 2605
High impedance 2116
No Known Device Problem 1849
Premature elective replacement indicator 1468
Failure to pace or properly pace 1431
Unknown (for use when the device problem is not known) 1331
No code available 1298
Normal 1263
Inappropriate shock 1057
No Information 1038
Failure to capture 1036
Device operates differently than expected 795
Device sensing issue 738
Malfunction 702
Noise 666
Mechanical issue 574
Device displays error message 539
Dislodged or dislocated 516
Connection issue 491
Low impedance 424
Device remains activated 379
Failure to interrogate 360
Undersensing 298
Alarm, error of warning 284
Loose or intermittent connection 261
Failure to shock or properly shock 256
Device alarm system issue 254
High sensing threshold 248
Impedance issue 222
Capturing issue 217
Communication or transmission issue 204
Connection error 178
Other (for use when an appropriate device code cannot be identified) 177
Inappropriate or unexpected reset 166
Defective item 164
Loss of threshold 164
Pocket stimulation 160
Material integrity issue 156
Difficult to interrogate 149
Reset issue 142
Fracture 141
Artifact 139
Failure to convert rhythm 126
Invalid sensing 124
High capture threshold 117
Ambient noise issue 116
Electrical issue 115
Pacer found in back-up mode 109
Delayed charge time 106
Difficult to insert 104
Battery issue 100
Use of Device Issue 98
Electro-magnetic interference (EMI) 93
Pacing inadequately 88
Migration of device or device component 86
Data Issue 82
Protective measure issue 82
Power source issue 79
Premature end-of-life indicator 77
Misconnection 76
Failure to deliver 76
Dislodged 74
Failure to sense 67
Unable to obtain readings 62
Output above specifications 58
Incorrect measurement 57
Interference 55
No device output 54
Material erosion 53
Output issue 51
Device damaged prior to use 50
Explanted 48
Unexpected therapeutic results 47
Shock counters, resetting of 46
Telemetry discrepancy 45
Performance 45
Device contamination with blood or blood product 42
Intermittent capture 42
False reading from device non-compliance 40
Fitting problem 39
Difficult to Program or Calibrate 39
Sensitivity 39
Low readings 38
Device remains implanted 37
Out-of-box failure 32
Sensing intermittently 32
Difficult to remove 27
Failure to charge 27
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 18
Incorrect display 18
Nonstandard device or device component 17
Total Device Problems 37054

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 1
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 St Jude Medical Inc. I Oct-21-2016
8 ela Medical Llc II Sep-27-2010

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