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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)
2015 2016 2017 2018 2019 2020
49 109 112 91 62 5

Device Problems
Adverse Event Without Identified Device or Use Problem 7985
Over-Sensing 6198
Premature Discharge of Battery 4150
High impedance 1841
Battery Problem 1647
Inappropriate Shock 1307
Failure to Capture 965
Inappropriate or Unexpected Reset 915
Pacing Problem 847
Electrical /Electronic Property Problem 660
Mechanical Problem 644
Device Dislodged or Dislocated 610
Device Sensing Problem 585
Failure to Interrogate 517
Ambient Noise Problem 443
Device Operates Differently Than Expected 427
Signal Artifact 427
Invalid Sensing 409
Capturing Problem 399
High Capture Threshold 307
Device Displays Incorrect Message 292
Under-Sensing 285
Communication or Transmission Problem 256
Defibrillation Problem 233
Appropriate Term/Code Not Available 224
Fracture 221
Connection Problem 218
Misconnection 211
Low impedance 191
Material Integrity Problem 185
Impedance Problem 182
Premature Elective Replacement Indicator 157
Electromagnetic Interference 156
Data Problem 150
Delayed Charge Time 133
Migration or Expulsion of Device 122
Incorrect Interpretation of signal 122
Device Alarm System 115
Defective Device 111
Pocket Stimulation 103
Failure to Deliver Shock 96
No Pacing 92
Unable to Obtain Readings 90
Pacemaker Found in Back-Up Mode 87
Premature End-of-Life Indicator 83
Use of Device Problem 82
Screw 80
Incorrect Measurement 78
Difficult to Insert 78
Difficult to Remove 77
Output Problem 74
Insufficient Information 73
Failure to Convert Rhythm 72
Failure to Charge 68
Protective Measures Problem 68
Telemetry Discrepancy 54
Fitting Problem 49
Break 48
Loose or Intermittent Connection 48
Wireless Communication Problem 45
Reset Problem 44
Separation Failure 40
Intermittent Capture 39
Unexpected Therapeutic Results 35
Failure to Sense 34
Guidewire 33
Patient-Device Incompatibility 33
Programming Issue 32
Migration 31
No Apparent Adverse Event 26
Difficult to Interrogate 25
Stylet 24
Insulation 22
Defective Alarm 22
Pacing Inadequately 22
Noise, Audible 21
No Device Output 20
Incorrect, Inadequate or Imprecise Result or Readings 20
Decreased Sensitivity 20
Component Missing 19
Failure to Select Signal 18
Failure to Advance 18
Vibration 15
Unintended Electrical Shock 15
Off-Label Use 15
Nonstandard device 14
Application Program Version or Upgrade Problem 14
Therapeutic or Diagnostic Output Failure 14
Missing Test Results 13
Interrogation Problem 13
Sensing Intermittently 12
Unstable Capture Threshold 11
Human-Device Interface Problem 11
False Alarm 10
Energy Output Problem 10
Failure to Disconnect 10
Positioning Problem 9
Device Contamination With Biological Material 9
Pacing Asynchronously 9
Header 8
Total Device Problems 37202

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Nov-08-2017
2 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-19-2017
3 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-07-2017
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
5 Sorin CRM SAS II Aug-15-2018
6 Sorin Group Italia SRL - CRF II Sep-28-2017
7 St Jude Medical Inc. II Jun-29-2018
8 St Jude Medical Inc. II Jun-12-2018
9 St Jude Medical Inc. I Oct-10-2017
10 St Jude Medical Inc. I Oct-21-2016

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