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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 5

Device Problems
Low battery 3733
Premature discharge of battery 3589
Oversensing 2630
High impedance 2148
No Known Device Problem 1897
Premature elective replacement indicator 1470
Failure to pace or properly pace 1448
Unknown (for use when the device problem is not known) 1331
No code available 1305
Normal 1263
Inappropriate shock 1084
Failure to capture 1051
No Information 1043
Device operates differently than expected 805
Device sensing issue 742
Malfunction 702
Noise 666
Mechanical issue 604
Device displays error message 552
Dislodged or dislocated 519
Connection issue 493
Low impedance 428
Device remains activated 379
Failure to interrogate 372
Undersensing 302
Alarm, error of warning 284
Loose or intermittent connection 263
Failure to shock or properly shock 263
Device alarm system issue 258
High sensing threshold 248
Impedance issue 227
Capturing issue 223
Communication or transmission issue 209
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 161
Material integrity issue 160
Difficult to interrogate 149
Invalid sensing 147
Fracture 144
Artifact 143
Reset issue 143
Ambient noise issue 131
Failure to convert rhythm 128
Electrical issue 125
High capture threshold 118
Pacer found in back-up mode 110
Delayed charge time 110
Difficult to insert 104
Battery issue 104
Use of Device Issue 99
Electro-magnetic interference (EMI) 94
Misconnection 91
Migration of device or device component 90
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 58
Output above specifications 58
Output issue 56
Interference 55
No device output 54
Material erosion 53
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 43
Intermittent capture 43
Fitting problem 41
False reading from device non-compliance 40
Sensitivity 39
Difficult to Program or Calibrate 39
Low readings 38
Device remains implanted 37
Out-of-box failure 32
Sensing intermittently 32
Difficult to remove 29
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 37711

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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