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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)
2014 2015 2016 2017 2018 2019
76 49 109 112 91 45

Device Problems
Adverse Event Without Identified Device or Use Problem 7290
Over-Sensing 6122
Premature Discharge of Battery 3834
High impedance 1754
Battery Problem 1442
Inappropriate Shock 1368
Failure to Capture 916
Inappropriate or Unexpected Reset 901
Pacing Problem 789
Mechanical Problem 602
Device Operates Differently Than Expected 594
Electrical /Electronic Property Problem 562
Device Dislodged or Dislocated 534
Failure to Interrogate 523
Device Sensing Problem 476
Ambient Noise Problem 444
Capturing Problem 414
Invalid Sensing 410
Signal Artifact 363
Device Displays Incorrect Message 316
High Capture Threshold 303
Under-Sensing 295
Low impedance 259
Connection Problem 258
Defibrillation Problem 233
Communication or Transmission Problem 232
Fracture 230
Misconnection 192
Appropriate Term/Code Not Available 192
Impedance Problem 179
Material Integrity Problem 173
Premature Elective Replacement Indicator 153
Delayed Charge Time 150
Electromagnetic Interference 121
Device Alarm System 117
Data Problem 115
Migration or Expulsion of Device 111
Incorrect Interpretation of signal 105
Screw 100
Pocket Stimulation 99
Output Problem 98
Defective Device 87
Premature End-of-Life Indicator 84
Insufficient Information 83
Pacemaker Found in Back-Up Mode 83
Difficult to Remove 82
Use of Device Problem 79
Unable to Obtain Readings 75
No Pacing 73
Difficult to Insert 66
Protective Measures Problem 64
Failure to Charge 64
Incorrect Measurement 62
Failure to Convert Rhythm 61
Failure to Deliver Shock 61
Telemetry Discrepancy 52
Intermittent Capture 49
Fitting Problem 45
Loose or Intermittent Connection 42
Break 42
Reset Problem 40
Difficult to Interrogate 38
Failure to Sense 37
Wireless Communication Problem 34
Programming Issue 32
Guidewire 31
Header 31
Unexpected Therapeutic Results 30
Patient-Device Incompatibility 27
Decreased Sensitivity 27
No Apparent Adverse Event 26
Insulation 26
Therapeutic or Diagnostic Output Failure 23
Separation Failure 22
Pacing Inadequately 21
Migration 21
No Device Output 20
Stylet 19
Noise, Audible 19
Defective Alarm 18
Nonstandard device 17
Component Missing 17
Vibration 15
Application Program Version or Upgrade Problem 14
Incorrect, Inadequate or Imprecise Result or Readings 14
Difficult To Position 13
Failure to Select Signal 12
Off-Label Use 12
Sensing Intermittently 12
Human-Device Interface Problem 12
Interrogation Problem 11
False Alarm 11
Difficult to Advance 11
Retraction Problem 10
Device Contamination With Biological Material 9
Unstable Capture Threshold 9
Low Battery 8
Positioning Problem 8
Lead 8
Pacing Asynchronously 8
Total Device Problems 35396

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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