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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 48

MDR Year MDR Reports MDR Events
2015 7822 7822
2016 13244 13244
2017 16252 16252
2018 8335 8335
2019 7248 7248
2020 6134 6134

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21732 21732
Over-Sensing 12213 12213
Premature Discharge of Battery 6911 6911
High impedance 2607 2607
Inappropriate/Inadequate Shock/Stimulation 2267 2267
Battery Problem 2031 2031
Inappropriate or Unexpected Reset 1601 1601
Failure to Capture 1517 1517
Pacing Problem 1290 1290
Device Operates Differently Than Expected 1024 1024
Device Dislodged or Dislocated 989 989
Electrical /Electronic Property Problem 963 963
Mechanical Problem 881 881
Device Sensing Problem 880 880
Failure to Interrogate 812 812
Signal Artifact/Noise 632 632
Under-Sensing 612 612
Invalid Sensing 579 579
Device Displays Incorrect Message 533 533
High Capture Threshold 530 530
Appropriate Term/Code Not Available 528 528
Ambient Noise Problem 446 446
Capturing Problem 435 435
Connection Problem 431 431
Defibrillation/Stimulation Problem 348 348
Communication or Transmission Problem 346 346
Low impedance 307 307
Fracture 306 306
Premature Elective Replacement Indicator 304 304
Misconnection 303 303
Electromagnetic Interference 300 300
Delayed Charge Time 234 234
Impedance Problem 233 233
Material Integrity Problem 219 219
Data Problem 216 216
Screw 198 198
Nonstandard Device 195 195
Device Alarm System 194 194
Migration or Expulsion of Device 184 184
Reset Problem 180 180
Incorrect Interpretation of Signal 174 174
Output Problem 172 172
Failure to Convert Rhythm 166 166
Insufficient Information 150 150
Defective Device 146 146
Failure to Deliver Shock/Stimulation 140 140
No Pacing 138 138
Unable to Obtain Readings 134 134
Difficult to Insert 128 128
Pacemaker Found in Back-Up Mode 126 126
Pocket Stimulation 124 124
Premature End-of-Life Indicator 124 124
Incorrect Measurement 119 119
Break 116 116
Protective Measures Problem 115 115
Difficult to Remove 111 111
Use of Device Problem 104 104
Loose or Intermittent Connection 101 101
Failure to Charge 89 89
Failure to Sense 81 81
Intermittent Capture 81 81
Wireless Communication Problem 71 71
Difficult to Interrogate 70 70
Separation Failure 66 66
Telemetry Discrepancy 64 64
Decreased Sensitivity 64 64
Insulation 62 62
Fitting Problem 61 61
Failure to Advance 56 56
Migration 54 54
Guidewire 52 52
Programming Issue 52 52
Incorrect, Inadequate or Imprecise Resultor Readings 48 48
Pacing Inadequately 45 45
Unexpected Therapeutic Results 43 43
Noise, Audible 42 42
Defective Alarm 37 37
Vibration 36 36
Patient-Device Incompatibility 35 35
Stylet 35 35
No Device Output 33 33
Therapeutic or Diagnostic Output Failure 33 33
No Apparent Adverse Event 29 29
Failure to Disconnect 28 28
Missing Test Results 26 26
Off-Label Use 26 26
Patient Lead 25 25
Therapy Delivered to Incorrect Body Area 22 22
Header 22 22
Inaccurate Synchronization 21 21
Component Missing 21 21
Charging Problem 19 19
Failure to Select Signal 18 18
Device Contamination with Body Fluid 18 18
Unintended Electrical Shock 18 18
Interrogation Problem 17 17
False Alarm 17 17
Sensing Intermittently 16 16
Unstable Capture Threshold 15 15
Human-Device Interface Problem 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 42431 42433
Unspecified Infection 4992 4992
No Consequences Or Impact To Patient 2451 2451
Death 1624 1624
Shock from Patient Lead(s) 1596 1596
No Patient Involvement 833 833
Sepsis 803 803
Hematoma 531 531
No Code Available 508 508
Syncope 482 482
Pocket Erosion 468 468
Therapeutic Effects, Unexpected 458 458
Ventricular Tachycardia 403 403
No Information 324 324
Ventricular Fibrillation 320 320
Dyspnea 313 313
Muscle Stimulation 296 296
Erosion 265 265
Dizziness 262 262
Pain 260 260
Complaint, Ill-Defined 256 256
Endocarditis 232 232
Device Overstimulation of Tissue 218 218
Discomfort 208 208
Cardiac Arrest 206 206
Fatigue 178 178
Arrhythmia 154 154
Bradycardia 150 150
Atrial Fibrillation 141 141
Chest Pain 140 140
Heart Failure 138 138
Swelling 137 137
Undesired Nerve Stimulation 132 132
Twiddlers Syndrome 130 130
Fever 112 112
Wound Dehiscence 109 109
Fall 99 99
Staphylococcus Aureus 93 93
Palpitations 84 84
Fainting 81 81
Bacterial Infection 70 70
Congestive Heart Failure 69 69
Weakness 62 62
Electric Shock 59 59
Pneumothorax 56 56
Low Blood Pressure/ Hypotension 55 55
Pericardial Effusion 51 51
Shock 50 50
Purulent Discharge 43 43
Tachycardia 42 42
Inflammation 39 39
Cardiopulmonary Arrest 36 36
Erythema 35 35
Loss of consciousness 35 35
Hypersensitivity/Allergic reaction 34 34
Pleural Effusion 34 34
Thrombosis 33 33
Septic Shock 29 29
Discharge 29 29
Nausea 29 29
Therapeutic Response, Increased 28 28
Complete Heart Block 28 28
Vascular Dissection 26 26
Impaired Healing 26 26
Cardiac Tamponade 25 25
Cardiomyopathy 24 24
Atrial Flutter 23 23
Atrial Tachycardia 23 23
Patient Problem/Medical Problem 23 23
Pneumonia 23 23
Hemorrhage/Bleeding 23 23
Bruise/Contusion 22 22
Cardiogenic Shock 22 22
Edema 21 21
Pulmonary Edema 21 21
Non specific EKG/ECG Changes 21 21
Myocardial Infarction 19 19
Thrombus 18 18
High Blood Pressure/ Hypertension 17 17
Vomiting 17 17
Anxiety 16 16
Chest Tightness/Pressure 16 16
Renal Failure 16 16
Chills 16 16
Respiratory Failure 16 16
Lethargy 13 13
Fluid Discharge 13 13
Abscess 13 13
Pulmonary Embolism 13 13
Numbness 12 12
Collapse 12 12
Cardiac Perforation 12 12
Necrosis 12 12
Stroke/CVA 12 12
Blood Loss 11 11
Post Operative Wound Infection 11 11
Exit Block 11 11
Perforation 11 11
Burning Sensation 10 10
Tingling 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-10-2020
2 Boston Scientific Corporation II Nov-08-2017
3 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-19-2017
4 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-07-2017
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
6 Sorin CRM SAS II Aug-15-2018
7 Sorin Group Italia SRL - CRF II Sep-28-2017
8 St Jude Medical Inc. II Jun-29-2018
9 St Jude Medical Inc. II Jun-12-2018
10 St Jude Medical Inc. I Oct-10-2017
11 St Jude Medical Inc. I Oct-21-2016
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