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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implantable cardioverter defibrillator (non-crt)
Definition These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Product CodeLWS
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
168 100 145 162 142 75

Device Problems
Over-Sensing 14618
High impedance 11516
Adverse Event Without Identified Device or Use Problem 10168
Inappropriate Shock 6334
Fracture 5031
Signal Artifact 4703
Premature Discharge of Battery 3724
Impedance Problem 3340
High Capture Threshold 3001
Device Displays Incorrect Message 2993
Device Sensing Problem 2469
Ambient Noise Problem 2184
Battery Problem 1932
Low impedance 1721
Device Operates Differently Than Expected 1664
Capturing Problem 1610
Pacing Problem 1590
Failure to Capture 1572
Under-Sensing 1559
Device Dislodged or Dislocated 1445
Inappropriate or Unexpected Reset 1109
Invalid Sensing 813
Device Alarm System 812
Failure to Interrogate 810
Appropriate Term/Code Not Available 800
Decreased Sensitivity 793
Material Integrity Problem 785
Mechanical Problem 780
Positioning Failure 732
Break 731
Defibrillation Problem 690
Connection Problem 679
Electrical /Electronic Property Problem 625
Communication or Transmission Problem 616
Delayed Charge Time 505
Activation, Positioning or Separation Problem 499
Failure to Convert Rhythm 481
Defective Device 373
Positioning Problem 350
Premature Elective Replacement Indicator 285
Unstable Capture Threshold 281
Electromagnetic Interference 271
Migration or Expulsion of Device 261
Insufficient Information 211
Failure to Charge 208
Failure to Select Signal 202
Protective Measures Problem 192
Difficult to Remove 166
Output Problem 163
Reset Problem 160
Premature End-of-Life Indicator 149
Data Problem 148
Screw 144
Misconnection 142
Nonstandard device 140
Insulation 136
Intermittent Capture 133
Unable to Obtain Readings 129
Loose or Intermittent Connection 127
Failure to Sense 123
Human-Device Interface Problem 121
Incorrect Interpretation of signal 120
Patient-Device Incompatibility 112
Pacemaker Found in Back-Up Mode 110
Incorrect Measurement 107
Interrogation Problem 93
Telemetry Discrepancy 80
Failure to Deliver Shock 73
Migration 72
Unexpected Therapeutic Results 71
Device-Device Incompatibility 69
Fitting Problem 63
Pocket Stimulation 63
Collapse 62
Noise, Audible 59
Use of Device Problem 54
No Audible Alarm 50
Programming Issue 49
Difficult to Interrogate 47
Header 46
Wireless Communication Problem 46
Device Contamination with Body Fluid 44
Bent 42
Difficult to Insert 40
No Pacing 39
Charging Problem 36
Therapeutic or Diagnostic Output Failure 35
Material Deformation 33
Unintended Electrical Shock 30
False Alarm 29
Device Contamination With Biological Material 29
Low Sensing Threshold 26
Stretched 26
Aborted Charge 23
Off-Label Use 23
Improper Alarm 22
Premature Activation 22
Energy Output Problem 22
Difficult To Position 21
No Device Output 20
Total Device Problems 102057

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific CRM Corp II Aug-05-2014
2 Boston Scientific Corporation II Sep-13-2019
3 Boston Scientific Corporation II Nov-16-2018
4 Boston Scientific Corporation II Sep-27-2018
5 Boston Scientific Corporation II Sep-27-2018
6 Boston Scientific Corporation II Nov-08-2017
7 Boston Scientific Corporation II Aug-16-2017
8 Boston Scientific Corporation II Feb-09-2017
9 Boston Scientific Corporation II Nov-06-2015
10 Medtronic Inc., Cardiac Rhythm and Heart Failure II Aug-25-2016
11 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2018
12 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
13 St Jude Medical Cardiac Rhythm Management Division I Jan-21-2016
14 St Jude Medical Cardiac Rhythm Management Division II Sep-03-2014
15 St Jude Medical Inc. I Aug-02-2019
16 St Jude Medical Inc. II Jun-29-2018
17 St Jude Medical Inc. I Oct-10-2017
18 St Jude Medical Inc. I Oct-21-2016
19 St Jude Medical Inc. II May-10-2016

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