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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)
2017 2018 2019 2020 2021 2022
24 19 20 23 18 0

MDR Year MDR Reports MDR Events
2017 415 415
2018 372 372
2019 345 345
2020 316 316
2021 579 579

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 385 385
Premature Elective Replacement Indicator 340 340
Over-Sensing 280 280
Premature End-of-Life Indicator 185 185
Inappropriate/Inadequate Shock/Stimulation 138 138
Failure to Interrogate 119 119
Battery Problem 117 117
High impedance 69 69
Premature Discharge of Battery 61 61
Communication or Transmission Problem 46 46
Device Operates Differently Than Expected 40 40
Device Displays Incorrect Message 35 35
Pacemaker Found in Back-Up Mode 34 34
Display or Visual Feedback Problem 31 31
Application Interface Becomes Non-Functional Or Program Exits Abnormally 29 29
Low impedance 29 29
Inappropriate or Unexpected Reset 26 26
Data Problem 21 21
Ambient Noise Problem 18 18
Interrogation Problem 15 15
Unexpected Therapeutic Results 14 14
Defibrillation/Stimulation Problem 14 14
Failure to Deliver Shock/Stimulation 13 13
Nonstandard Device 13 13
Failure to Capture 12 12
Insufficient Information 11 11
High Capture Threshold 11 11
Device Sensing Problem 11 11
No Pacing 10 10
Wireless Communication Problem 10 10
Unexpected Shutdown 10 10
Connection Problem 7 7
Impedance Problem 7 7
Electromagnetic Interference 7 7
Fracture 7 7
Difficult to Interrogate 6 6
Migration or Expulsion of Device 6 6
Reset Problem 6 6
Loss of Data 6 6
Appropriate Term/Code Not Available 6 6
No Apparent Adverse Event 6 6
Application Program Freezes, Becomes Nonfunctional 5 5
Delayed Charge Time 5 5
Device Markings/Labelling Problem 5 5
Intermittent Capture 5 5
No Display/Image 5 5
Failure to Transmit Record 5 5
Mechanical Problem 5 5
Failure to Power Up 4 4
Failure to Sense 4 4
Low Battery 4 4
Under-Sensing 4 4
Electrical /Electronic Property Problem 4 4
Pacing Problem 4 4
Programming Issue 4 4
Inaccurate Information 4 4
Therapeutic or Diagnostic Output Failure 3 3
Operating System Becomes Nonfunctional 3 3
Device Operational Issue 3 3
Issue With Displayed Error Message 3 3
Charging Problem 3 3
Pacing Inadequately 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Unable to Obtain Readings 2 2
Failure to Convert Rhythm 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Disconnect 2 2
Pacing Intermittently 2 2
Loose or Intermittent Connection 2 2
Incorrect Measurement 2 2
Computer Software Problem 2 2
Break 2 2
Calibration Problem 2 2
Device Dislodged or Dislocated 2 2
Missing Information 2 2
Unstable Capture Threshold 2 2
Missing Test Results 1 1
Patient Data Problem 1 1
Unintended Application Program Shut Down 1 1
Intermittent Communication Failure 1 1
Fail-Safe Did Not Operate 1 1
Migration 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Electromagnetic Compatibility Problem 1 1
Flare or Flash 1 1
Detachment of Device or Device Component 1 1
Application Program Version or Upgrade Problem 1 1
Battery Impedance Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1
Operating System Version or Upgrade Problem 1 1
Output Problem 1 1
Power Problem 1 1
Scratched Material 1 1
Signal Artifact/Noise 1 1
Failure to Back-Up 1 1
Failure to Conduct 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 553 553
No Clinical Signs, Symptoms or Conditions 537 537
No Information 329 329
Unspecified Infection 292 292
Shock from Patient Lead(s) 67 67
No Consequences Or Impact To Patient 50 50
Death 32 32
No Patient Involvement 26 26
Pocket Erosion 24 24
Electric Shock 15 15
Insufficient Information 15 15
Ventricular Tachycardia 14 14
Ventricular Fibrillation 11 11
Pain 11 11
Hematoma 8 8
Sepsis 8 8
Endocarditis 7 7
Arrhythmia 7 7
Bacterial Infection 6 6
Dyspnea 6 6
Cardiac Arrest 6 6
Discomfort 6 6
Syncope/Fainting 6 6
Implant Pain 5 5
Shock 5 5
Dizziness 5 5
Heart Failure 4 4
Atrial Fibrillation 4 4
Syncope 4 4
Staphylococcus Aureus 4 4
No Code Available 4 4
Asystole 3 3
Pneumonia 3 3
Wound Dehiscence 3 3
Bradycardia 3 3
Chest Pain 3 3
Anxiety 3 3
Swelling 3 3
Occlusion 2 2
Distress 2 2
Cardiogenic Shock 2 2
Loss of consciousness 2 2
Bruise/Contusion 2 2
Pneumothorax 2 2
Fainting 2 2
Fatigue 2 2
Fever 2 2
Headache 2 2
Necrosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Blister 1 1
Twiddlers Syndrome 1 1
Swelling/ Edema 1 1
Fluid Discharge 1 1
Neuropathy 1 1
Hemothorax 1 1
Low Blood Pressure/ Hypotension 1 1
Perforation 1 1
Scar Tissue 1 1
Raynauds Phenomenon 1 1
Right Ventricular Hypertrophy 1 1
Cardiopulmonary Arrest 1 1
Cellulitis 1 1
Congestive Heart Failure 1 1
Connective Tissue Disease 1 1
Muscle Stimulation 1 1
Abrasion 1 1
Autoimmune Reaction 1 1
Erosion 1 1
Needle Stick/Puncture 1 1
Palpitations 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Toxicity 1 1
Malaise 1 1
Numbness 1 1
Coma 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Fibrosis 1 1
Not Applicable 1 1
Discharge 1 1
Viral Infection 1 1
Burning Sensation 1 1
Tingling 1 1
Tachycardia 1 1
Thyroid Problems 1 1
Twiddlers Syndrome 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
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