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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device defibrillator, implantable, dual-chamber
Product CodeMRM
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
20 28 16 19 24 20 18 20 24 19 20 23 18 9 20 2

MDR Year MDR Reports MDR Events
2014 320 320
2015 292 292
2016 383 383
2017 415 415
2018 372 372
2019 345 345
2020 316 316
2021 575 575
2022 505 505
2023 557 557
2024 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Elective Replacement Indicator 961 961
Adverse Event Without Identified Device or Use Problem 655 655
Over-Sensing 513 513
Premature End-of-Life Indicator 403 403
Inappropriate/Inadequate Shock/Stimulation 288 288
Failure to Interrogate 227 227
Battery Problem 137 137
High impedance 113 113
Premature Discharge of Battery 112 112
Device Displays Incorrect Message 75 75
Communication or Transmission Problem 73 73
Display or Visual Feedback Problem 70 70
Pacemaker Found in Back-Up Mode 70 70
Ambient Noise Problem 68 68
Low impedance 66 66
Device Operates Differently Than Expected 62 62
Insufficient Information 51 51
Inappropriate or Unexpected Reset 48 48
Application Interface Becomes Non-Functional Or Program Exits Abnormally 39 39
Defibrillation/Stimulation Problem 37 37
Data Problem 32 32
Connection Problem 28 28
Impedance Problem 26 26
Failure to Capture 23 23
Reset Problem 20 20
Failure to Deliver Shock/Stimulation 19 19
Nonstandard Device 19 19
Unexpected Therapeutic Results 19 19
High Capture Threshold 19 19
Wireless Communication Problem 18 18
Failure to Transmit Record 17 17
Under-Sensing 16 16
Fracture 16 16
No Pacing 16 16
Interrogation Problem 16 16
Device Sensing Problem 15 15
Application Program Freezes, Becomes Nonfunctional 14 14
Appropriate Term/Code Not Available 13 13
Loss of Data 12 12
Low Battery 12 12
Difficult to Interrogate 12 12
Migration or Expulsion of Device 12 12
Signal Artifact/Noise 11 11
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Pacing Problem 11 11
Unexpected Shutdown 10 10
Computer Software Problem 9 9
Erratic or Intermittent Display 9 9
Electromagnetic Interference 9 9
Delayed Charge Time 9 9
Issue With Displayed Error Message 9 9
No Apparent Adverse Event 8 8
Electrical /Electronic Property Problem 8 8
Pacing Inadequately 8 8
Unable to Obtain Readings 7 7
Failure to Sense 7 7
Failure to Convert Rhythm 7 7
Loose or Intermittent Connection 7 7
No Display/Image 7 7
Intermittent Capture 7 7
Therapeutic or Diagnostic Output Failure 7 7
Programming Issue 7 7
Incorrect Or Inadequate Test Results 7 7
Telemetry Discrepancy 6 6
Defective Component 6 6
Operating System Becomes Nonfunctional 6 6
Failure to Power Up 6 6
Noise, Audible 6 6
Program or Algorithm Execution Problem 6 6
Mechanical Problem 5 5
Patient Data Problem 5 5
Installation-Related Problem 5 5
Device Markings/Labelling Problem 5 5
Device Operational Issue 4 4
Device Dislodged or Dislocated 4 4
Packaging Problem 4 4
Application Program Problem 4 4
Charging Problem 4 4
No Device Output 4 4
Incorrect Interpretation of Signal 4 4
Missing Test Results 4 4
Inaccurate Information 4 4
Missing Information 3 3
Erratic Results 3 3
Unstable Capture Threshold 3 3
Migration 3 3
Pacing Intermittently 3 3
Break 3 3
Misconnection 3 3
Material Erosion 3 3
Defective Device 3 3
Incomplete or Missing Packaging 3 3
Radiofrequency Interference (RFI) 2 2
Failure to Disconnect 2 2
Failure to Calibrate 2 2
Date/Time-Related Software Problem 2 2
Invalid Sensing 2 2
Contamination /Decontamination Problem 2 2
Power Problem 2 2
Operating System Version or Upgrade Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1477 1477
No Known Impact Or Consequence To Patient 1068 1068
Unspecified Infection 470 470
No Information 420 420
Shock from Patient Lead(s) 177 177
No Consequences Or Impact To Patient 116 116
Insufficient Information 65 65
Death 59 59
Electric Shock 49 49
No Patient Involvement 41 41
Pocket Erosion 35 35
Pain 29 29
Ventricular Fibrillation 23 23
Shock 21 21
Hematoma 20 20
Ventricular Tachycardia 19 19
Patient Problem/Medical Problem 19 19
Discomfort 18 18
Endocarditis 16 16
Sepsis 15 15
Atrial Fibrillation 14 14
Cardiac Arrest 14 14
No Code Available 14 14
Syncope 13 13
Bacterial Infection 12 12
Arrhythmia 9 9
Tachycardia 9 9
Implant Pain 8 8
Syncope/Fainting 8 8
Staphylococcus Aureus 7 7
Chest Pain 7 7
Dyspnea 7 7
Fatigue 6 6
Wound Dehiscence 6 6
Dizziness 6 6
Twiddlers Syndrome 5 5
Heart Failure 5 5
Failure of Implant 5 5
Not Applicable 5 5
Anxiety 5 5
Loss of consciousness 5 5
Palpitations 4 4
Pneumonia 4 4
Pneumothorax 4 4
Swelling 4 4
Bradycardia 4 4
Fainting 4 4
Fall 4 4
Congestive Heart Failure 3 3
Necrosis 3 3
Asystole 3 3
Coma 2 2
Foreign Body In Patient 2 2
Myocarditis 2 2
Distress 2 2
Malaise 2 2
Twiddlers Syndrome 2 2
Missing Value Reason 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Low Blood Pressure/ Hypotension 2 2
Perforation 2 2
Occlusion 2 2
Viral Infection 2 2
Cardiogenic Shock 2 2
Cellulitis 2 2
Bruise/Contusion 2 2
Fever 2 2
Headache 2 2
Hemorrhage/Bleeding 2 2
Inflammation 2 2
Liver Damage/Dysfunction 1 1
Nausea 1 1
Hemothorax 1 1
Hyperbilirubinemia 1 1
Foreign Body Reaction 1 1
Dehydration 1 1
Cardiomyopathy 1 1
Cardiopulmonary Arrest 1 1
Connective Tissue Disease 1 1
Muscle Stimulation 1 1
Abrasion 1 1
Erosion 1 1
Atrial Tachycardia 1 1
Autoimmune Reaction 1 1
Shock, Traumatic 1 1
Discharge 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Therapeutic Effects, Unexpected 1 1
Thyroid Problems 1 1
Burning Sensation 1 1
Tingling 1 1
Scar Tissue 1 1
Seizures 1 1
Raynauds Phenomenon 1 1
Local Reaction 1 1
Right Ventricular Hypertrophy 1 1
Neuropathy 1 1
Swelling/ Edema 1 1
Impaired Healing 1 1
Ventilator Dependent 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BIOTRONIK Inc II Apr-21-2021
2 Sorin Group Italia SRL - CRF II Sep-28-2017
3 Sorin Group Italia SRL - CRF II May-18-2017
4 Sorin Group USA, Inc. II Mar-08-2013
5 ela Medical Llc II Jun-22-2011
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