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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)
2015 2016 2017 2018 2019 2020
100 145 162 142 98 5

Device Problems
Over-Sensing 14456
High impedance 11936
Adverse Event Without Identified Device or Use Problem 10944
Inappropriate Shock 5935
Fracture 5352
Signal Artifact 5058
Premature Discharge of Battery 3828
Impedance Problem 3535
High Capture Threshold 3222
Device Displays Incorrect Message 2983
Device Sensing Problem 2644
Ambient Noise Problem 2175
Battery Problem 2078
Low impedance 1745
Pacing Problem 1658
Capturing Problem 1652
Failure to Capture 1617
Under-Sensing 1593
Device Dislodged or Dislocated 1546
Device Operates Differently Than Expected 1472
Inappropriate or Unexpected Reset 972
Mechanical Problem 837
Material Integrity Problem 823
Invalid Sensing 813
Decreased Sensitivity 809
Device Alarm System 804
Failure to Interrogate 772
Appropriate Term/Code Not Available 768
Positioning Failure 760
Break 756
Defibrillation Problem 654
Connection Problem 650
Electrical /Electronic Property Problem 649
Communication or Transmission Problem 624
Activation, Positioning or Separation Problem 515
Failure to Convert Rhythm 483
Delayed Charge Time 470
Defective Device 428
Positioning Problem 374
Unstable Capture Threshold 308
Electromagnetic Interference 285
Premature Elective Replacement Indicator 279
Migration or Expulsion of Device 264
Failure to Select Signal 248
Failure to Charge 226
Protective Measures Problem 200
Premature End-of-Life Indicator 169
Reset Problem 166
Difficult to Remove 166
Data Problem 162
Misconnection 153
Patient-Device Incompatibility 151
Insufficient Information 143
Intermittent Capture 140
Unable to Obtain Readings 138
Nonstandard device 133
Incorrect Interpretation of signal 130
Insulation 128
Loose or Intermittent Connection 128
Output Problem 125
Human-Device Interface Problem 121
Screw 116
Failure to Sense 111
Pacemaker Found in Back-Up Mode 111
Incorrect Measurement 110
Interrogation Problem 104
Failure to Deliver Shock 89
Migration 87
Telemetry Discrepancy 80
Unexpected Therapeutic Results 78
Noise, Audible 75
Device-Device Incompatibility 73
Pocket Stimulation 68
Collapse 67
Fitting Problem 64
Use of Device Problem 55
Programming Issue 49
No Audible Alarm 49
Wireless Communication Problem 47
Unintended Electrical Shock 45
Device Contamination with Body Fluid 44
No Pacing 42
Bent 41
Difficult to Insert 37
Charging Problem 37
Difficult to Interrogate 35
Material Deformation 35
Stretched 29
Low Sensing Threshold 28
Device Contamination With Biological Material 28
False Alarm 27
Energy Output Problem 26
Header 25
Off-Label Use 25
Premature Activation 23
No Device Output 22
Difficult To Position 21
Device Contamination with Chemical or Other Material 21
Missing Test Results 20
Component Missing 20
Total Device Problems 104417

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

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