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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device artificial heart
Definition P030011
Product CodeLOZ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1 2 2 5 3 7 7 10 11 5 8 5 0 2 6 1

MDR Year MDR Reports MDR Events
2014 325 325
2015 421 421
2016 422 422
2017 291 291
2018 569 569
2019 379 379
2020 264 264
2021 241 241
2022 152 152
2023 167 167
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 703 703
Audible Prompt/Feedback Problem 552 552
Adverse Event Without Identified Device or Use Problem 493 493
Device Operates Differently Than Expected 332 332
Battery Problem 292 292
Noise, Audible 222 222
Mechanical Problem 202 202
Appropriate Term/Code Not Available 161 161
Electrical /Electronic Property Problem 137 137
Output Problem 111 111
Power Problem 94 94
No Apparent Adverse Event 89 89
Break 87 87
Charging Problem 80 80
Failure to Charge 78 78
Device Alarm System 69 69
Display or Visual Feedback Problem 67 67
Connection Problem 46 46
Device Operational Issue 40 40
Device Inoperable 38 38
Physical Property Issue 36 36
Material Integrity Problem 33 33
Loose or Intermittent Connection 32 32
No Display/Image 32 32
Filling Problem 29 29
Image Display Error/Artifact 29 29
Material Puncture/Hole 24 24
Crack 24 24
Difficult to Insert 23 23
Premature Discharge of Battery 22 22
Insufficient Information 22 22
Low Battery 20 20
Device Stops Intermittently 19 19
Temperature Problem 18 18
Air Leak 17 17
Detachment Of Device Component 17 17
False Alarm 16 16
Component Falling 15 15
Disconnection 15 15
Difficult to Remove 14 14
Device Dislodged or Dislocated 14 14
Material Discolored 13 13
Failure to Power Up 13 13
Torn Material 13 13
Computer Operating System Problem 13 13
Defective Alarm 13 13
Fracture 12 12
Device Emits Odor 11 11
Pressure Problem 11 11
Failure of Device to Self-Test 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1155 1155
No Known Impact Or Consequence To Patient 984 984
No Clinical Signs, Symptoms or Conditions 618 618
No Patient Involvement 593 593
Death 231 231
Bacterial Infection 133 133
Respiratory Failure 127 127
Hemorrhage/Bleeding 106 106
Renal Failure 102 102
Multiple Organ Failure 98 98
Neurological Deficit/Dysfunction 86 86
Loss of consciousness 63 63
Patient Problem/Medical Problem 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Hemolysis 40 40
Sepsis 36 36
Liver Damage/Dysfunction 34 34
No Information 32 32
Stroke/CVA 31 31
No Code Available 30 30
Fungal Infection 27 27
High Blood Pressure/ Hypertension 26 26
Renal Impairment 24 24
Urinary Tract Infection 21 21
Unspecified Infection 20 20
Thromboembolism 15 15
Low Cardiac Output 13 13
Dizziness 13 13
Viral Infection 11 11
Thrombosis/Thrombus 11 11
Discomfort 10 10
Dyspnea 8 8
Complaint, Ill-Defined 8 8
Pulmonary Edema 6 6
Pulmonary Embolism 6 6
Hemorrhage, Cerebral 6 6
Fall 6 6
Insufficient Information 6 6
Pericardial Effusion 5 5
Fatigue 5 5
Cardiomyopathy 5 5
Wound Dehiscence 5 5
Hypervolemia 5 5
Encephalopathy 5 5
Headache 4 4
Convulsion/Seizure 4 4
Right Ventricular Failure 4 4
Bowel Perforation 3 3
Ischemia 3 3
Edema 3 3

Recalls
Manufacturer Recall Class Date Posted
1 SynCardia Systems Inc. I Dec-08-2016
2 SynCardia Systems Inc. I Sep-17-2015
3 SynCardia Systems LLC II Oct-20-2023
4 SynCardia Systems LLC II Jan-27-2023
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