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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 65

Device Problems
Low battery 3733
Premature discharge of battery 2869
Oversensing 2502
High impedance 1931
No Known Device Problem 1640
Premature elective replacement indicator 1458
Failure to pace or properly pace 1353
Unknown (for use when the device problem is not known) 1331
No code available 1283
Normal 1262
No Information 1028
Inappropriate shock 992
Failure to capture 949
Device operates differently than expected 757
Device sensing issue 708
Malfunction 702
Noise 666
Device displays error message 510
Dislodged or dislocated 484
Mechanical issue 484
Connection issue 467
Low impedance 414
Device remains activated 379
Failure to interrogate 334
Undersensing 293
Alarm, error of warning 284
Loose or intermittent connection 256
High sensing threshold 248
Failure to shock or properly shock 238
Device alarm system issue 237
Impedance issue 200
Communication or transmission issue 197
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 161
Material integrity issue 149
Difficult to interrogate 148
Pocket stimulation 146
Capturing issue 141
Reset issue 139
Artifact 137
Failure to convert rhythm 123
High capture threshold 115
Fracture 110
Difficult to insert 104
Pacer found in back-up mode 104
Delayed charge time 100
Electrical issue 89
Pacing inadequately 88
Use of Device Issue 87
Electro-magnetic interference (EMI) 86
Data Issue 81
Power source issue 79
Failure to deliver 76
Protective measure issue 74
Dislodged 74
Migration of device or device component 74
Premature end-of-life indicator 71
Battery issue 70
Invalid sensing 69
Ambient noise issue 67
Failure to sense 62
Output above specifications 58
Interference 55
Unable to obtain readings 54
No device output 54
Material erosion 53
Misconnection 53
Device damaged prior to use 50
Incorrect measurement 49
Explanted 47
Unexpected therapeutic results 47
Output issue 47
Shock counters, resetting of 46
Telemetry discrepancy 45
Performance 45
Device contamination with blood or blood product 41
False reading from device non-compliance 40
Intermittent capture 40
Difficult to Program or Calibrate 39
Sensitivity 39
Low readings 38
Device remains implanted 37
Out-of-box failure 32
Sensing intermittently 31
Fitting problem 27
Installation-related problem 27
Device Issue 26
Product quality issue 26
Difficult to remove 25
Contamination during use 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 35034

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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