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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 72

Device Problems
Over-Sensing 17003
High impedance 13987
Adverse Event Without Identified Device or Use Problem 12892
Inappropriate/Inadequate Shock/Stimulation 7396
Signal Artifact/Noise 6402
Fracture 6400
Impedance Problem 4157
Premature Discharge of Battery 4133
High Capture Threshold 3935
Device Sensing Problem 3259
Device Displays Incorrect Message 3018
Ambient Noise Problem 2175
Low impedance 2048
Pacing Problem 1960
Under-Sensing 1932
Failure to Capture 1858
Capturing Problem 1842
Device Dislodged or Dislocated 1833
Battery Problem 1595
Device Operates Differently Than Expected 1459
Decreased Sensitivity 1009
Inappropriate or Unexpected Reset 991
Mechanical Problem 955
Material Integrity Problem 931
Break 881
Appropriate Term/Code Not Available 870
Positioning Failure 830
Device Alarm System 819
Invalid Sensing 813
Electrical /Electronic Property Problem 780
Failure to Interrogate 762
Connection Problem 717
Defibrillation/Stimulation Problem 669
Communication or Transmission Problem 645
Defective Device 633
Failure to Convert Rhythm 601
Activation, Positioning or SeparationProblem 581
Delayed Charge Time 482
Positioning Problem 442
Electromagnetic Interference 403
Failure to Read Input Signal 374
Unstable Capture Threshold 364
Failure to Select Signal 324
Premature Elective Replacement Indicator 293
Migration or Expulsion of Device 279
Failure to Charge 255
Protective Measures Problem 221
Data Problem 211
Premature End-of-Life Indicator 206
Reset Problem 189
Difficult to Remove 183
Misconnection 172
Insufficient Information 167
Insulation 166
Patient-Device Incompatibility 166
Intermittent Capture 162
Interrogation Problem 158
Unable to Obtain Readings 151
Incorrect Interpretation of Signal 145
Migration 141
Loose or Intermittent Connection 136
Nonstandard Device 133
Noise, Audible 133
Human-Device Interface Problem 129
Failure to Sense 127
Incorrect, Inadequate or Imprecise Resultor Readings 125
Output Problem 122
Failure to Deliver Shock/Stimulation 118
Incorrect Measurement 112
Pacemaker Found in Back-Up Mode 107
Screw 105
Unexpected Therapeutic Results 104
Telemetry Discrepancy 88
Device-Device Incompatibility 82
Collapse 76
Pocket Stimulation 75
No Apparent Adverse Event 71
Use of Device Problem 66
Fitting Problem 62
Inaccurate Synchronization 59
Unintended Electrical Shock 57
No Audible Alarm 52
Device Contamination with Body Fluid 50
Wireless Communication Problem 47
Programming Issue 47
No Pacing 42
Difficult to Insert 41
Bent 41
Material Deformation 39
Material Twisted/Bent 37
Off-Label Use 36
Low Sensing Threshold 36
Charging Problem 35
Stretched 32
Energy Output Problem 29
Device Contamination With Biological Material 28
Difficult to Interrogate 28
False Alarm 28
Power Problem 27
Header 24
Total Device Problems 121211

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Mar-03-2020
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 Inc. I Aug-02-2019
15 St Jude Medical Inc. II Jun-29-2018
16 St Jude Medical Inc. I Oct-10-2017
17 St Jude Medical Inc. I Oct-21-2016
18 St Jude Medical Inc. II May-10-2016

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